Job Title: Quality Assurance Manager
Company: Nanosphere Inc.
Location: Northbrook, IL
Description:
Company Overview Nanosphere, Inc. (NASDAQ: NSPH) is a nanotechnology-based molecular diagnostics company, offering proprietary breakthrough technologies that provide a unique and powerful solution to greatly simplify molecular diagnostic testing. Based in Northbrook, IL, Nanosphere employs approximately 110 people. Nanosphere’s diagnostic platform has several FDA cleared tests and the company continues with its ambitious growth plans of rapidly bringing new tests and device platforms with enhanced capabilities to the marketplace. Position Overview Nanosphere is committed to recruiting an outstanding Quality Assurance Manager during a critical period of the Company’s growth and evolution. The QA Manager will report to a Senior Staff Member of the Company. A key success factor for this position is the ability to work in a fast paced, cross functional group environment, with a willingness to be hands-on across a wide area of responsibilities. This ideal candidate is someone with diverse experience and great capacity and desire for taking on new responsibilities and challenges as the company grows. This position is responsible for developing, implementing and maintaining the Company’s Quality Assurance Systems for developing and manufacturing in-vitro diagnostic (IVD) products in the areas of nucleic acid and protein testing. Key Responsibilities: • Responsible for the development and maintenance of Nanosphere Quality Assurance (QA) Systems. Nanosphere's QA Systems include: Document Controls; Purchasing Controls; Identification and Traceability; Production and Process Control; CAPAs; Labeling and Packaging; Material and Product Handling, Storage and Distribution; Equipment Installations; Manufacturing Records; Maintenance and Service. • Working with senior management, ensure the Company’s QA system is fully compliant with Quality System Regulations (QSRs) that meet FDA and ISO expectations. • Write, review, implement and improve as necessary the standard operating procedures for the QA Systems. • Interface with Analytical Development, Manufacturing, Development, Facilities, and Quality Control to effectively implement procedures throughout the company that comply with the applicable FDA QSRs and to monitor on-going progress in procedure and process improvement. • Review and approve batch records, change requests, non-conformance and OOS investigations, and prepare Certificate of Compliance for disposition of manufactured product. ? Responsible for optimizing incoming material receiving, intermediate releases, and final product acceptance and release. ? Participate as QA representative on various teams and committees. ? Audit material suppliers and other vendors such as contract manufacturers and contract analytical laboratories used for QC testing. ? Lead regular reviews of QA Systems with Nanosphere senior management. ? Provide QSR Training to Nanosphere personnel. Experience and Requirements: ? Experience with development of Quality Systems required for Medical Devices and/or diagnostics. ? Ability to easily interpret QSR requirements (21CFR820) and must have demonstrated past successes in implementing the applicable QSRs into QA Systems for organizations that have successfully both designed and manufactured IVD and/or medical devices. ? Familiarity with global regulatory requirements that pertain to product development and IVD manufacturing (e.g. CE IVD mark). ? Excellent communication skills and ability to work in a changing environment on complex projects. Outstanding teamwork and project management skills; ability to interact with external and internal customers on fast-paced projects. ? Minimum 7 yrs experience working in a QA role in a company that has designed and manufactured an IVD or medical device using QSRs. ? Degree in Chemistry, Engineering, Life Sciences, or related field. Advanced degree is not required. EOE m/f/d/v
Job Title: Quality Assurance Manager
Company: Campbell's Soup Company
Location: Chicago, IL
Description:
Requisition Number : 5979Job Title : Quality Assurance ManagerPosition Type : Full TimeJob Type : Manufacturing/Operations & EngineeringCompany : Pepperidge Farm IncorporatedBusiness Unit / Location : Downers Grove PlantDescription : Take the opportunity to work with one of America's best-loved and well-recognized brand icons. With annual sales exceeding $1 billion, eight manufacturing facilities across the country, and 5,000 employees committed to excellence, Pepperidge Farm? makes careers rise like fresh bread in a hot oven.We are the nation's quality and good-taste leader in premium baked goods, from crunchy Goldfish? crackers to decadent Milano cookies, from savory Swirl breads to zesty Texas Toast.General SummaryLead and manage the entire range of Quality programs, as defined in the Pepperidge Farm Quality Policies and CSC North American Quality Policies. Position has specific compliance, process, and consumer quality responsibilities. Position will manage a set of matrix relationships within Quality, and R&D, to influence senior management on alignment of Quality strategies, Quality annual objectives, and Plant project plans. Individual will coordinate and deploy Quality Assurance programs across Pepperidge Farm plants, and functional areas, and influence plant leadership with quality best practices.Principal Accountabilities1. 50% - Develop, drive, and continually improve a comprehensive quality program as defined by the Pepperidge Farm QPM and CSC North American Quality Policies. (Compliance Quality)2. 25% - Drive process improvement initiatives through staff, work group, Pepperidge Farm Quality staff, and R&D (Process Quality)3. 25% - Manage & Drive Consumer Complaint programs, initiatives, and consumer delight models for each businessJob ComplexityResponse to new or changes in regulations on specifications, procedures, quality, and implications where utilized in a range of finished product.. Trouble shooting quality issues across the varied supply chains for ingredients, packaging, materials, and finished products supplied (examples; mixed labels, allergen risk management, equipment risk management, container nonconformance).Job Specifications. Expert abilities and decision quality in Food Safety, Regulatory, and Quality Systems and their application within food processing.. Expert knowledge in Sanitation and GMP Practices, familiarity with Pest Control programs and techniques. Knowledge of Quality Standards, and Quality Policies, with skills and ability to execute against requirements.. Knowledge and general business acumen to support and influence Manufacturing, including best practices and innovative technologies.. Knowledgeable in industry Food Safety/Quality audit practices, and skilled in adapting to achieve business best practices.. Capable of engaging other businesses unit quality in development and standardization of; Quality manuals, policies, procedures, and data templates, audit standards and procedures, and Quality Key Performance Indicators.. Knowledgeable in Statical Process Control programs and Process capability studies. Ensures plant personnel is technically capable of handling non-routine quality system issues and that issues are investigated, documented, and resolved.. Record of leadership and demonstrated success in collaborative development, documentation, planning, and implementation and continuous improvement of quality systems.. Ability to drive organizational alignment on Quality objectives with an enterprise-wide mindset, and the adaptation of structure, processes, and systems to achieve objectives.. Capable of influencing development steps used in the Innovation and Commercialization process to leverage Design in achieving consumer safety and quality objectives (example; HACCP Assessment).. Assertive, Outspoken, yet collaborative. Demonstrated skills influencing components of the company, tough-mindedness, vision, and political savvy to manage internal and external relationships and situations.. Dedicated work habits, takes initiative, sets high standards. Knowledgeable and capable of collaboration on quality programs; drives improvement of consumer based specifications.. Minimum BS Food Science (or related degree), and a minimum 8-10 years of food industry quality plant/systems experience with demonstrated achievement in Quality leadership.. Aware of Continuous Improvement tools.Working ConditionsTravel is estimated at 5%-10%.CAMPBELL SOUP COMPANYwww.campbellsoup.comCampbell Valuing People, People Valuing CampbellCampbell Soup Company is an Equal Opportunity EmployerState/Province : IllinoisCity : Downers GroveRelocation Approved : Possible
Job Title: Quality Assurance Manager
Company: Company Confidential
Location: Carol Stream, IL
Description:
Affiliated Computer Services, Inc. (ACS) is expertise in action™. We are a FORTUNE 500 company with 74,000 employees worldwide supporting client operations reaching more than 100 countries. We provide business process outsourcing and information technology solutions to world-class commercial and government clients. Our employees operate with integrity, and are flexible, reliable and responsive. If you meet the requirements of this position and want to work for a world-class company with a great marketplace reputation, apply today. May perform one or more of the following: Functional Description: The Quality Assurance Manager is a member of middle/second level management who applies a comprehensive working knowledge of payment processing and call-center quality concepts, practice and procedures. The QA Manager is responsible for development, implementation, and leads key process improvement efforts and influences cross-functional efforts. Also, responsible for the employment promotion, counseling, and discipline of assigned employees. The QA Manager works independently with only general management direction; may work at client site(s); and typically reports to senior management. REPRESENTATIVE PRINCIPAL DUTIES AND RESPONSIBILITIES: ILSDU Quality Assurance Manager Key Quality Assurance Duties: · Ensure that all reports for the Client are completed on time and accurately. · Ensure that all internal reports for operations and other departments are completed accurately and timely. · Act as the coordinator for any ad-hoc reporting requests from both external and internal clients. · Act as the audit coordinator for key external and internal audits · Thoroughly research and report upon, in a timely manner, any issues or concerns (i.e. contract compliance, audit, or fraud) that the external client, or internal employees raise. · Troubleshoot questions of data accuracy and anomalies. · Proactively audit, review and, where necessary, build operational processes. · Develop and suggest process improvements that lead to cost savings, improved documentation and/or higher quality performance. · Manage small projects on an as needed basis. · Ensure all procedures for the project are kept up-to-date in a version-controlled format. Education and Typical Years of Experience: ACS is an Equal Opportunity Employer and does not Discriminate against any applicant on the basis of race, color, religion/creed, national origin, gender, or sex, marital status, age, disability, use of a guide dog or service animal, sexual orientation, military/veteran status, or any other status protected by Federal or State law or local ordinance. People with disabilities who need a reasonable accommodation to apply or compete for employment with ACS may request such accommodations by calling or by sending an e-mail to Register to View -.
Job Title: Quality Assurance Manager (Supervisor)
Company: Systems Research Inc
Location: Schaumburg, IL
Description:
3 plus years of experience in the Food industry. Bi-lingual is a plus, Knowledge of HACCP, GMP's, FDA, safety.
Description:
Company Profile: Decatur Electronics Inc designs, manufactures and markets the finest speed measurement products and traffic safety equipment in the world. Our radar products are used for law enforcement, sports, industrial/OEM and scientific applications. In addition, our radar message trailers are the finest quality and most rugged in the industry, with extra bright LED characters. Our digital in car video is amazingly versatile and easily upgradable. Decatur, IL is home to our corporate headquarters and primary production facilities. Our company currently has close to 100 employees, plus a sales network of professional manufacturers, representatives and distributors. We sell in all 50 states, as well as globally through our international distribution network. With a management team comprised of seasoned professionals in their respective fields, we are totally committed to preeminence in technology, sales and customer service. Position Summary: Due to recent corporate advancement, we are currently looking for a Quality Manager. The Quality Manager will be responsible for our ISO 9001:2000 procedures, continually improving the quality and manufacturing processes and making sure the product built meets or exceeds our customer’s expectations of quality and reliability. Responsibilities:Plan and manage all work related to Quality including incoming inspection, floor inspection, in-progress inspection, electrical test and final test. Create, document and implement inspection criteria and procedures.Develop and analyze statistical data and product specifications to determine standards and to establish quality and reliability expectancy of finished products. Investigate and correct customer issues and complaints relating to quality.Formulate, document and maintain quality control standards and objectives.Management representative for ISO audit purposes, documentation and policies / procedures.Updating and writing SOPs, analytical methods, forms, specifications and other quality system documentation.Aid in the development of new product and develop testing procedures that insure quality is built in the product and improves its manufacturability. Requirements:Bachelor’s degree in engineering or quality assurance discipline or equivalent preferred. 7-10 years experience in a senior quality role in a manufacturing setting.3 + years experience in company-wide ISO 9001:2000 lead auditing.Experience working in an electronic assembly or electronics environment a plus.Proficient in the use of Failure Effect Mode Analysis. (ME or EM)Proficient in data collection, analysis and presentation
Job Title: Quality Assurance Manager
Company: All-Rite Spring Co.
Location: Spring Grove, IL
Description:
BSALITY ASSURANCE MANAGER -- Spring manufacturer looking for a full time experienced leader for our Quality Department. Ideal candidate will hold a BS in Mechanical Engineering, experience with automotive industry requirements, ISO/TS 16949, and ensure training of QA technicians, lab testing and customer quality systems and programs. Must have good interpersonal and communication skills. Some travel required. Please send resume including salary requirements to: ARSC, Attention: HR Dept, 2302 Spring Ridge Dr, Spring Grove, IL 60081
Job Title: Manager, Quality Assurance
Company: Westinghouse
Location: Lake Bluff, IL
Description:
Westinghouse, a group company of Toshiba Corporation, is the world's pioneering nuclear power company and is a leading supplier of nuclear plant products and technologies to utilities throughout the world. We help our customers produce reliable and environmentally-friendly electricity by enhancing nuclear plant availability and dependability, and by reducing operation and maintenance costs.We are currently seeking a Manager of QA/QC over all of our organizations within WEC Welding & machining, located at our Lake Bluff Facility, within our Global Field Services group. Based out of Lake Bluff, IL WEC Welding & Machining specializes in welding and machining applications at both nuclear and non-nuclear sites around the world.Qualified Candidate will:*Responsible for budget management, personnel evaluations, behavioral observation (fitness for duty rules) *Technical expert in QA requirements pertaining to welding implementation and inspection. *Give direction to PCI, WEMS and CES QA/QC for daily activities such as work locations and shifts to be worked, travel arrangements, and applicable regulations/requirements. *Function as the technical lead for all QA/QC efforts support of PCI, WEMS and CES organizations in meeting corporate responsibilities and customer requirements/expectations related to Quality Assurance and Quality Control. *Perform lead quality assurance functions in the commercial nuclear industry for projects, programs, systems, and product lines of significant scope for nuclear and non-nuclear projects at Westinghouse and customer and supplier sites. *Provide technical leadership and project management skills to integrate project teams across multifunctional areas. *Responsibilities will also include obtaining and maintaining ASME Certifications requisite to enabling PCI, WEMS and CES access to desired markets. *Prepare for and obtain successful outcomes of various audits by customers, regulatory agencies, vendors, and other groups.*Act as quality liaison/coordinator for third party inquiries including customers, regulatory agencies, licensees, ASME, ISO, etc., and for internal departments on quality issues.*Responsible for oversight of the Corrective Action Program as Corrective Action Manager (CAM) in accordance with WEC 16.2.*Responsible for management of the PCI, WEMS and CES commitment to the Corrective Action metrics and communication to the Leadership Team.
Job Title: QUALITY ASSURANCE MANAGER
Company: The Judge Group
Location: Chicago, IL
Description:
Job ID: JO142280Job Title: QUALITY ASSURANCE MANAGERJob Type: PermanentCompany: JUDGE GROUPLocation: IllinoisContact E-mail: Register to View : 12Description: A Growing Snack Food company is in search of a QA manager for their facility in the Midwest. The individual must have a background in R&D,Food Safety and QA. A four year degree is a must along with 5+ years of related experience. The individual will be over 2 plants that employs about 200 people.
Job Title: Quality Assurance Manager
Company: Radio Flyer
Location: Chicago, IL
Description:
Radio Flyer, is a highly regarded, privately held toy manufacturer based in Chicago, Illinois. Recognized as one of Americas premier toy companies, this 90 year-old, family run business is known for producing top quality, beautifully designed products. Beyond the classic red wagon, Radio Flyer has dramatically expanded the product line during the past five years. Each new product reflects the companys longstanding commitment to quality, safety, and service. Having achieved record growth and increased visibility in the market place, the aggressive leadership team is investing resources and strengthening the company for an exciting and prosperous future. This newly created position will be based in the Chicago with the responsibility for implementing programs to insure the highest level of product quality, safety and performance. The selected candidate will collaborate across the organization to integrate quality programs into the design, development, manufacturing and distribution of products. Responsibilities include: * Develop quality assurance and inspection plans to insure all products adhere to industry toy standards (ASTM/ANSI/EN71) and customer requirements. * Partner with product development to create quality and safety guidelines for all new products. * Define performance and reliability expectations for all new and existing products. * Work with Radio Flyer offices in Hong Kong and China to insure the quality of all shipments meet our expectations. * Establish quality standards for all factories and implement a vendor quality audit process which rewards/penalizes performance. * Develop consumer problem reporting tools and resources (training, reference materials and technical support) to improve customer service. The ideal candidate will have a minimum of 8 years of quality engineering experience with a toy, sporting goods, housewares, or related consumer products company. It is critical that this candidate have knowledge of the product development cycle, including quality testing. This position is ideally suited for a team player with entrepreneurial spirit and outstanding communications skills. Proven ability to work effectively with vendors in China and overcome language/cultural barriers is essential. The right candidate will have a working knowledge of the ASTM and EN71 toy standards and have experience working with independent product testing laboratories.
Job Title: Quality Assurance Manager
Company: Delta
Location: Melrose Park, IL
Description:
Delta Scientific is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together. Come be a part of our success story!Job Title Quality Assurance ManagerPosition Description This position will be responsible for establishing, implementing, and maintaining Quality Systems SOPs and Analytical Test Methods related to technical transfer activities associated with the manufacturing integration of over 100 SKUs. The candidate will be responsible for review and approval of analytical data, product technical transfer protocols, stability studies etc. and will manage analytical investigations (equipment, stability, out of specification (OOS).Position Responsibilities This role will focus on technical and operational quality decisions associated with product transfer actives such as: leadership skills, self motivation, integrity, ethics and a solid commitment to drug safety.Approving and auditing test method transfers / verifications Approving and auditing stability dataApproving and auditing technical transfer protocols and final reports Approving technical transfer related documentation (e.g., SOPs, Master Batch Records, and Investigation Reports etc.The position will be working directly with the technical transfer team and site staff to integrate the products on time and on budget.Position Requirements Review and approve analytical data package for API, finished drug products and stability Write, review, and approve SOPs, test methods, specifications, protocols, reports, and other documentation related to QC and analytical testingPerform a comprehensive review and assessment of stability data (e.g., OOS investigations) Prepare stability sections for regulatory/QC documents in support of PASs and CBEsManage with site staff the qualification/validation of analytical methods, approval of validation protocols and reports, specifications, batch records and changes related to methods and specifications