QC Director Jobs in Massachusetts

Job Title: Quality Management Officer Company: Department of Veterans Affairs Location: Bedford, MA Description: QUALITY MANAGEMENT OFFICER VETERANS ADMINISTRATION BEDFORD, MA You are invited to apply for the full-time position of (Quality Management Officer) for the New England Healthcare System - VISN 1 Network Office located in Bedford, MA. The (Quality Management Officer) is a member of the VISN 1 executive staff and organizationally reports directly to the Network Director. The VA New England Healthcare System is one of 21 Veterans Integrated Service Networks (VISNs) within the U.S. Department of Veterans Affairs (VA) and is located throughout the six New England states - Maine, New Hampshire, Vermont, Massachusetts, Rhode Island and Connecticut. Services are provided through primary care supported by eight (8) Joint Commission accredited medical centers, over 35 Community Based Outpatient Clinics (CBOCs), six (6) nursing homes and two (2) domiciliaries. You will function as the (Quality Management Officer) and be designated Network Manager for the VISN 1 Performance Management Consolidated Program (PMCP). You will be responsible for program development, coordination, evaluation and personnel and budgetary management network-wide. Program supervision and coordination responsibilities encompass the Network QMO Office quality, performance and safety team and network coordination and oversight of quality management programs at eight healthcare divisions, including a substantial number of Community Based Outpatient Clinics. Play a critical role in organizational performance improvement as a member of the interdisciplinary team, working closely with staff at all levels of the organization to enhance the quality, appropriateness and timeliness of patient care and services promotion continuous improvement. You should be a US citizen, hold an MD or DO degree or an equivalent degree resulting from a course of education in medicine OR hold a masters degree in nursing and, you must have a current, full and unrestricted license to practice medicine or surgery in a State, Territory, or Commonwealth of the United States, or in the District of Columbia. Located in scenic New England, you will be within a one-half hour drive from Boston and a three-hour drive from New York City. Bedford abounds with cultural, recreational and educational opportunities. For more information, E-mail your CV to Don Rainwater, National Healthcare Recruitment Consultant, Register to View

Job Title: Assoc Director Quality Company: Genzyme Location: Allston, MA Description: Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzymes people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortunes list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzymes local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success.Quality Assurance Associate Director, Allston, Bulk Protein ManufacturingJob Responsibilities/Department description:This individual will report to the Director of Quality Assurance Operations for Allston and will be responsible for providing leadership and technical management of the Quality Assurance group supporting Bulk Protein Manufacturing Operations. The position will have five direct reports. The primary responsibilities of the group include real-time oversight of manufacturing operations (buffer and media prep, cell culture, purification, and formulation); product release; continuous improvement; and approval of master documents and executed records.Major responsibilities include:Develop, improve, and monitor quality systems to achieve best in class performanceEnsure departmental and site procedures are aligned with regulatory requirements and corporate quality standardsActively partners and collaborates with key stake holders during planning and process improvement activities to ensure timely completion of all operational areas objectives and milestones consistent with site priorities and objectives.Develop a cohesive team, maintaining and reinforcing a strong quality presence in the manufacturing areas, and encouraging constructive relationships with manufacturing and support groupsSupport an environment of staff development and learning; mentoring and developing personnel, including supervisory/management staff via timely feedback, robust developmental discussions, and documented goals/objectivesDevelop and execute hiring plans, ensuring that requisitions are filled in a timely mannerOversee record review and lot release processes for bulk intermediatesManage immediate response to deviations, in partnership with other operations groups; identify, contain and mitigate risk in a 7 day/3 shift working environment; ensure thorough investigation of root causes, and the implementation of effective CAPAsApprove validation plans and protocolsDevelop and manage departmental budget in cooperation with direct staffThe Quality Assurance Associate Director works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors; exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Job Title: DIRECTOR OF QUALITY SYSTEMS Company: Plainfield Precision Location: Plymouth, MA Description: COMPANY/JOBPlainfield Precision is a leading manufacturer of custom precision metal and plastic components and assemblies for the medical, automotive, electrical, appliance, and consumer industries.  As a global company, we take great pride in our state-of-the-art manufacturing equipment and facilities.  We invest in talent, training, and innovative technology to produce QUALITY PRODUCTS, provide EXCEPTIONAL CUSTOMER SERVICE, and promote ORGANIZATIONAL GROWTH.Plainfield Precision is committed to maintaining and continuously improving our quality systems.  The Director of Quality Systems is a corporate position that will engage globally with all Plainfield Precision locations, customers, and suppliers.  Reporting directly to our President/COO, he/she will also have dotted-line responsibility to divisional Quality Managers.  It will be based out of our Plymouth, Massachusetts location, but all qualified applicants may be considered.RESPONSIBILITIESThe two primary responsibilities for this position include:1) Coordinating the adherence and certification of quality systems.  Maintaining current certifications of ISO9000 and TS16949 in various locations, ensuring standardization and compliance, driving and performing internal audits, achieving additional certifications, such as ISO 13485, as required.  The position will include being the Quality management representative for the company and coordinating audit schedules.  Successful deliverables include:Maintenance of quality certifications in all divisions, compliance with minimal findingsAchieving new certifications to agreed scheduleStandardization of procedures and best practicesEffective system of internal auditingMaintenance to auditing budget 2) Leading the incorporation of continuous improvement culture within all divisions.  This will include teaching and training continuous improvement skills, identifying and grooming champions in each division, leading 5S and kaizen events to eliminate waste and organize the work environment, and measuring, documenting and presenting progress.   Successful deliverables include:Evidence of a growing continuous improvement culture within the companyMeasurable progress in the elimination of waste, improved efficiency, and costDevelopment of an official continuous improvement program Other duties may be assigned, such as:Working with customers on major quality related projectsWorking on significant new business development projects in the companyInterfacing with suppliers on problem solving or improvement activities.Assisting purchasing dept. with supplier qualifications and performance. EDUCATION/SKILLS REQUIREDCollege Degree Required.  Engineering or Business preferredAppropriate Engineering or Manufacturing experience required.Any industry credential or certifications in ISO and Continuous Improvement (Lean, Six Sigma, etc.)Skilled user of Microsoft office products, enterprise applications, familiarity with Force. Com applications a plusWorking understanding of Lean Principles and the ability to lead and instill continuous improvement into the company culture MINIMUM QUALIFICATIONS/EXPERIENCEMinimum of 15 Years of Manufacturing experience, automotive and/or medical fields preferredMust have ISO or TS ExperienceWorking experience with clients directly and ability to speak publically is a plusMust have experience using continuous improvement tools such as Lean and 6 SigmaGreen / black belt certification is a plusExperience in integrated molding/stamping arena is preferredDemonstrated resume of accomplishmentTEAM oriented individual with excellent communication skills Ability to travel domestically and internationally We offer a competitive salary and a comprehensive benefits package.  Apply on-line.  For consideration, include resume (in Word) with salary history and/or requirements.Equal Opportunity Employer

Job Title: Quality Manager/Director Company: IDEX Corporation Location: Middleboro, MA Description: As IDEX Health and Science - Middleboro, we are home of Sapphire Engineering and Isolation Technology products serving analytical instruments, biotech, and IVD markets. We recently moved into our new best-of-class 80,000 square foot facility in Middleboro, MA, near the I-495/Route 44 intersection. We are part of the Northbrook, IL based IDEX Corporation, a $1.4 billion applied solutions company with nearly 5000 employees and operations on six continents. Together we serve a highly diverse set of customers who look to our company to provide applied engineered fluidic and mechanical solutions to our exacting specifications, anywhere in the world. Although ours are the recognized brand names of the industrial world, we produce hundreds of products that touch people's lives every day.SUMMARYFacilitates and oversees the quality function and the development of quality based, process driven policies, procedures and metrics throughout the company including product development, vendor quality programs, and manufacturing operations. Responsible for maintenance of the ISO program, audits, certification and procedures/business processes. The individual will work in a highly performance driven, matrixed, high-paced environment and must drive initiatives through earning credibility throughout each function of the organization. This individual will manage projects through indirect or "sphere-of-influence" forms of management.ESSENTIAL JOB FUNCTIONSThe individual will work independently and must drive initiatives through earning credibility throughout each function of the organization. Individual will manage projects through indirect or "sphere-of-influence" forms of management. • Responsible for overseeing the Quality Management System, Inspection and Customer Returns. This position has the overall authority and responsibility as Middleboro's ISO Management Representative. This responsibility includes: Ensuring the processes needed for the quality management system are established implemented and maintained. Periodic reporting to the top management on the performance of the quality management system and any need for improvement, Ensuring and promoting the awareness of customer requirements throughout the organization. • Perform random inspections of shop floor production and ensure effective methodologies for maintaining and improving product quality. Manages non-conforming materials system including WIP rejects and incoming materials. Support operations management in assessing material and process defects in support of corrective action programs.• In conjunction with the Materials function, actively and continuously pursue improvements in supplier quality, OTD, auditing and supplier corrective actions. Effective communication of all variances to the organization in a timely manner. • Interface with multiple departments, levels of management, customers and vendors. • Complete and disseminate metric reports. • Maintain ISO certification, perform audits and work with auditors to improve processes. • Will travel up to 25% to customer and vendor sites. • Lead special projects as assigned. • Assist with LEAN manufacturing implementations. • Prepare and present training on quality and products. • Lead and or participate in BVSM (Business Value Stream Mapping) and VSM (Value Stream Mapping) projects. • Prepare and present various analytical reports for management review to aid in root cause analysis and solutions. QUALIFICATIONS Bachelor's degree in Business, Engineering or a related field. 7+ years of progressive experience in Quality Assurance and a minimum of three years management/supervisory experience in a Quality functional environment. Comprehensive knowledge of quality assurance practices and processes. Previous ISO certification, audit and improvement experience. Excellent written/verbal/teaching skills with attention-to-detail. Demonstrated PC, Microsoft Word and Excel skills. Experience or training in Six Sigma or TQM, ISO and Lean fundamentals preferred. • Must have a working knowledge of formal quality programs and lab procedures, with experience with a variety of measuring/inspection instruments, test and auditing equipment. • Formal experience and training in multi-disciplined project/program management required. Desirable Traits Self-starter with ability to work independently. Ability to work in both a team environment and autonomously. Excellent listening skills and attention to detail. Multi-task oriented with ability to manage multiple projects and ensure goals and timelines are met. JOB CONDITIONS Work environment includes a laboratory setting, an office environment and extensive exposure to a production environment. It also encompasses conference room and classroom settings, and other meeting environments. PHYSICAL ACTIVITIES REQUIRED TO PERFORM ESSENTIAL FUNCTIONS The physical/mental capabilities described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. • The employee frequently is required to sit for long hours. Has need for good hand and body dexterity for repetitive use of computer keyboard and hand tools. • The employee is occasionally required to stand, walk, and reach with hands and arms. • The employee must occasionally lift and/or move up to 25 pounds. • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus for reading computer screen and other normal activities of this position. • Must be able to travel (by air, train, bus and/or automobile) to customer and supplier sites throughout the world. Travel estimated to comprise up to 25% of job related activities. • Maintain composure and professional approach when dealing with public. • Ability to make decisions logically. • Capable of focusing on details with regards to procedures and workflow. • Speaking and hearing ability for telephone and in-person communications. • Communicate clearly in English verbally and in writing. Apply Here!

Job Title: Quality Manager Company: Manpower Location: Leominster, MA Description: We are searching for a Quality Manager with a manufacturing background for our client. This is a permanent position located in the Leominster area. The Quality Manager will be responsible for all functions within the organization; Marketing & Sales, Research & Development, Operations/Manufacturing, Finance & Control, Demand Chain Supply Management and Purchasing.Our candidate will have 1-3 years managing direct reports in a QC environment, ISO 9001, SAP knowledge and extensive experience in a quality environment within a manufacturing capacity. Our candidate will have 6-10 years in a QC/QA manufacturing environment. Please send your resume and cover letter to Register to View and reference "Quality Manager 1MP" in the subject of your email. Manpower is an Equal Opportunity Employer (EOE/AA)

Job Title: Director Quality Control Chemistry Company: Genzyme Location: Allston, MA Description: Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzymes people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortunes list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzymes local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success.Job TitleDirector Quality Control Chemistry Allston Landing FacilityJob Responsibilities/Department description:-Develops/defines the overall QC Chemistry strategy and vision for Allston Landing Facility in alignment with evolving corporate and global laboratory standards, quality system element remediation, regulatory inspection information, external benchmarking and best practices resulting in robust inspection readiness and alignment.-Routinely assesses and determines optimal organizational structure and resource requirements to assure compliant performance and timely completion of priorities in a 7day/3 shift working environment.-Insures and procures adequate staffing levels to flawlessly maintain QC Chemistry release cycle times, projects and continuous improvement initiatives consistent with plan.-Provides senior management and staff key input, direction and leadership in support of complex QC Chemistry challenges related to site initiatives and objectives.-Directs the development, planning, implementation and maintenance of QC Chemistry test methods, processes and operations.-Actively develops strategies and actions to continuously improve data management practices and test method reliability and repeatability assuring inspection readiness and on time release expectations.-Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, root cause analysis and risk assessments.-Actively participates and influences the development and formalization of corporate laboratory control standards, policies and guidelines-Actively partners and collaborates with key stake holders during planning and process improvement activities to ensure timely completion of all operational areas objectives and milestones consistent with site priorities and objectives.-Mentors and develops personnel, including supervisory/management staff via robust developmental discussions, external feedback and documented goals/objectives.Routinely assesses key talent and establishes a succession plan for all managerial personnel.-Defines framework for department objectives, operation schedule, processes and budgets.-Provides key input and documentation during external and internal regulatory compliance inspections.-Assures test method validation requirements, laboratory controls and compendial compliance are always in state of inspection readiness.-Develops key performance indicators that will drive laboratory performance expectations and improvement.-Work is performed without appreciable direction. Determines organizational objectives. Completed work is reviewed, from a relatively long-term perspective, for desired results.Generally accomplishes results through lower management levels.

Job Title: Clinical Research Operations Quality Manager Company: Genzyme Location: Cambridge, MA Description: Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzymes people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortunes list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzymes local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success.PURPOSE OF THE POSITION: To implement and manage internal quality control and oversight procedures in Clinical Operations to secure and maintain compliance with ICH GCP and other applicable international regulations, as well compliance with internal SOPs, systems, processes and standards. The position will instill concepts of quality management, continuous improvement, and inspection readiness so that Clinical Research programs can consistently withstand inspections by internal QA or external regulatory authorities globally.CORE RESPONSIBILITIES:Analyze and track all audit reports globally (internal QA or Regulatory Authority audits) to insure that responses and corrective actions applicable to Clinical Operations are completed and audits are closed in a timely manner.Generate, coordinate, and track Corrective and Preventative Action Plans (CAPA) within Clinical Operations.Determine the need for new processes or revisions to processes (e.g. SOPs, Work Instructions).Determine the need for training programs or revisions to training curricula.Act as the primary contact and resource for Clinical Operations during regulatory inspections by competent authorities. Support project teams and coordinate resources in planning and responding during inspections.Track and ensure that all staff in Clinical Operations is current with training requirements.Assist in the review and development or revision of processes and best practices (SOPs).Assist in the development of training programs in Clinical Operations (SOPs and GCP).In collaboration with other process owners in Clinical Operations (e.g. Monitoring, TMF), evaluate metrics for compliance with predetermined performance criteria, particularly in regard to study monitoring and reporting functions (e.g. Monitoring Visits, report generation, Monitoring Manual preparation and compliance).Establish and manage inspection readiness requirements so that all documents and systems are up to date and readily accessible (e.g. Trial Master File maintenance, Clinical Trial Management System maintenance and other requirements)Develop a Compliance Plan for Genzyme staff, contractors, vendors and CROs and track conformity to the compliance plan - CVs, Job Descriptions, organizational charts, training records.Develop Inspection Readiness guidance documents and training to assist project teams in establishing inspection readiness both internally, and with vendors or contract research organizations.Train and lead staff in quality and continuous improvement initiatives.Develop compliance and performance dashboards along with periodic summary reportsDevelop and maintain business continuity plans and contact information required during disruptions of normal business functions.

Job Title: Quality Control Manager Company: Location: Worcester, MA Description: Packaging company is interested in hiring an experienced QC manager with experience in flexible packaging but will consider backgrounds in plastics, printing, or other manufacturing areas. QC will report directly to plant manager. Full benefits and relocation assistance.

Job Title: Quality Manager Company: Location: Worcester, MA Description: SMC began its commitment to plastic injection molding, engineering and manufacturing nearly 2 decades ago. Today SMC is a renowned business leader across the globe specializing in contract manufacturing of medical devices based on a platform of injection molding. We pride ourselves in creating a business to top notch customer service while maintaining a family oriented organization. Position Scope and Purpose: Responsible for all areas of Quality Engineering and working directly with the engineering, tooling and manufacturing functions making sure adequate systems and inspection methods and tools are used throughout the plants for molding or assembling products. Understanding customer requirements and implementing action plans, purchasing equipment or tools necessary to perform tasks. Ensure proper controls, operator instructions and quality tools used to verify customer?s products at all phases within our process. Duties and Responsibilities: ? Review daily rejects or complaints and implement or discuss action plans ? Disposition In-Process rejected product from previous day (MRB), if required ? Make appropriate changes in documentation to prevent recurrence ? Make appropriate changes to fixtures or inspection methods and tools ? Create/Modify and Maintain History Cards/ Control Plans ? Make decisions regarding quality related questions as appropriate ? Contact customers via verbal/written communication as appropriate ? Create/Maintain FMEA?s, Control Plans, Validation Plans, IQ/OQ/PQ protocol?s, PPAP?s as appropriate ? Participate in design reviews as required ? Visit customers with regards to customer complaint resolutions ? Participate in plant/department meetings and tours as required ? Review PPAP, FAIR?s, Validation Data, and M&P studies before sending to customer ? Work with Engineering, MFG and Tooling to develop corrective actions and continuous improvement activities. ? Report any unsafe conditions to Manager or Safety committee member ? Maintain cleanliness of work areas and quality measuring equipment ? Observe all health and safety requirements ? Perform any and all other duties assigned Desired Qualifications: ? 2-4 year college degree or Quality related experience. ? Minimum of 5 years experience in a Quality Engineering ? Must be able to read and understand 2D detailed part/article drawings ? Must understand the use all Quality related inspection equipment ? Must have excellent problem solving and mistake proofing skills ? Must have computer skills and familiarity with Word and Excel programs ? Must have knowledge of SPC and ISO 9001 & 13485 system requirements ? Ability to work well with others and independently ? Excellent written, verbal, and presentation skills ? Ability to lift up to 30 lbs.

Job Title: Manager Quality Control Company: Genzyme Location: Westborough, MA Description: Genzyme Genetics is an award-winning national provider of highly sophisticated diagnostic testing, including prenatal, postnatal and neonatal as well as oncology testing. We are one of the largest diagnostic locations around the United States and a growing international portfolio. We also provide Genetic Counseling services. We are best known for our high quality, innovation, unique menu and commitment to a clear and positive impact on patient care. Additionally, we are a leader in personalized medicine and forging relevant connections between diagnostics and therapeutics.As a division of Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, we are committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzyme Corporation has been selected by FORTUNE magazine as one of the 100 Best Companies to Work For in 2006 in the United States, and ranked #6 Employer among the worlds Top 20 Biotechnology and Pharmaceutical Companies.SummaryWe are currently seeking a Quality Control Manager for our high throughput clinical molecular genetics testing laboratory in Westborough, MA. This hands-on manager will be responsible for supervising the daily activities of a QC team dedicated to supporting the sample extractions and assay laboratories, as well as providing some support for other sites within the Genzyme Genetics network. This is a highly technical role providing oversight of the teams responsibilities to provide high quality reagents and materials to numerous internal customers.This individual will also serve as one of the organizations technical experts on a variety of assays, providing support in the areas of experimental design and analysis, troubleshooting, and continuous process improvement.Job ResponsibilitiesManage the day-to-day activities of the laboratorys Quality Control operations, including the methods and processes surrounding the provision of high-quality reagents to theclinical molecular genetics laboratory. Provide leadership, support and direction and ensure compliance with all QC SOPs. Assign and prioritize team and individual QC responsibilities. This includes the supervision of a small team and all related personnel management responsibilities such as hiring, goal setting, team building, and performance evaluations.Review molecular and other QC data, according to laboratory SOPs and CLIA and CAP standards. Coordinate approvals, troubleshooting, and problem resolution in collaboration with clinical assay supervisors.Oversee the qualification of several hundreds of reagents and supplies. Develop qualification procedures and acceptance criteria for all qualified reagents. Analyze QC data in conformance with in-house, generally accepted clinical DNA diagnostic laboratory and, increasingly, in accordance with cGMP standards for quality. Establish QC metrics for the continuous monitoring of reagent performance in production.Apply deep technical knowledge in clinical chemistry, molecular biology, or biochemistry to provide high-level technical expertise on the troubleshooting of current assays and the scale-up and transfer of new assays and technologies into the production laboratory. Mentor team members in the application of good experimental design, using statistical dataanalysis and DOE what is this? where applicable.Develop processes for the controlled release and tracking of quality-controlled reagents to on-site and remote testing laboratories. Manage all production supply ordering and inventory tracking in collaboration with the Materials Management group.Develop new SOPs and perform SOP revisions while adhering to formal document control procedures and regulatory requirements.Serve as primary QC contact; maintain inter- and intra-group interactions through effective communication; coordinate critical QC interactions with other areas of the molecular genetics lab; collaborate with QA, Development and Assay groups in technical transfer of new tests according to launch timelines; participate in weekly Supervisors meetings; participate in Core teams for new product development and launch by providing review and recommendations on technical aspects of project.Initiate and perform change controls for instrumentation, processes, and materials related to the quality control processes.