Quality Systems Engineer Jobs

Job Title: Quality Engineer (Native Software) Company: Location: Birmingham, AL Description: Every day, Kelly Engineering Resources (KER) connects engineering professionals with opportunities to advance their careers. We currently have an exciting direct hire opportunity for a Quality Engineer with medical device experience in Birmingham, AL. Responsibilities and prospects for professional growth include: - Assist the Engineering function with required New Product Development (NPD) and Continuing/Sustaining activities to include Risk Management File creation and Biocompatibility testing. - Interface with Operations/Manufacturing to assure that quality considerations and requirements are adequately covered in manufacturing procedures, equipment selection, bill of materials and other quality, manufacturing documentation, and records. - Perform process & line evaluations/validations as changes are made and/or new products are developed. - Support Software Intended Use Validations (SIUV) to ensure compliance to standards such as 21 CFR Part 11. - Conduct internal/supplier audits of quality management functions, processes, and procedures over which the Quality Engineer has no direct control or responsibility. - Support of other Quality Systems such as Corrective and Preventive Actions (CAPA), Supplier Corrective Actions, and Document Control. - Provide direction to quality technician(s) and engineers in attaining and maintaining quality, preventing defects, and achieving improvement. - Provide team skills training and statistical support as required. Experience and Education and experience required: - Five years experience in a medical device (U.S. FDA-regulated and registered) manufacturing environment in a Quality Engineering and/or Supplier Quality Assurance role. - Good working knowledge of 21CFR820, ISO 13485:2000, ISO 14971, and ISO 10993. - Knowledge of Staistical Process Control (SPC) and auditing systems. - Standard computer software and internet use (MSWord, Excel, Access, etc.) proficiency required. - SolidWorks, AutoCad, or Pro-E design software experience/knowledge required. - ASQ certification (e.g., Quality Manager, Engineer, Auditor) preferred. For immediate consideration, click the 'Apply Now!' button, or refer a friend by clicking the 'E-mail this job' link provided. Kelly Engineering Resources® specializes in providing companies around the world with qualified engineers, designers, drafters, and technicians. We are part of Kelly Services®, a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyengineering.com Kelly Services'Celebrating 60 Years Kelly Services is an Equal Opportunity Employer.

Job Title: Quality Engineer IV Company: Location: Milpitas, CA Description: Headquartered in Singapore, Flextronics is a leading Electronics Manufacturing Services (EMS) provider focused on delivering complete design, engineering and manufacturing services to automotive, computing, consumer digital, industrial, infrastructure, medical and mobile Original Equipment Manufacturers (OEM)s. With the acquisition of Solectron, pro forma fiscal year 2007 revenues from continuing operations are more than US$30 billion. Flextronics helps customers design, build, ship, and service electronics products through a network of facilities in 35 countries on four continents. This global presence provides design and engineering solutions that are combined with core electronics manufacturing and logistics services, and vertically integrated with components technologies, to optimize customer operations by lowering costs and reducing time to market. For more information, please visit www.flextronics.com . Purpose: Support business growth in medical and other market segments . Principle Accountabilities: The Quality Engineer will: Perform Medical and other product quality assurance Risk assessment, process and equipment validation, maintenance protocols, training and audits Maintenance of Quality Management System consistent with ISO13485 and FDA QSR. Customer-facing responsibilities as "technical expert" through all phases of business development and sustaining production operations. Requirements: BS or BA, or equivalent. 5 +years Quality Engineering experience. Comprehensive understanding of QMS requirements per ISO standards. ASQ CQE or CQA certification. Proficiency in statistical analysis, statistical process control, and root cause analysis corrective and preventive action Strong human relations and both verbal and written communication skills. Desktop productivity tool proficiency (Word, Excel, Access, Visio). Experience in medical device manufacture or repair. Mastery of ISO13485: 2003 standard and FDA QSR requirements. Electronics manufacturing or repair related experience involving customer interaction and new product introduction. Strong leadership skills, and ability to manage and balance numerous assignments and conflicting requirements. Click here to apply for this job http://flextronics.ats.hrsmart.com/cgi-bin/pm/click.cgi?job_id=11013&site_id=123

Job Title: Quality Engineer Company: Location: Minneapolis, MN Description: We are looking for a Quality Assurance Engineer immediately to join one of our exciting medical device clients. Duties and Responsibilities: Evaluate quality concerns of the performance of medical devices and components from the production floor and/or field. Respond to production quality concerns on a daily basis. Determine cause of concern. .Interface with production planning, engineering, purchasing and receiving inspection regarding vendor rejects. Participate in development and implementation of quality policies and procedures. Assist manufacturing engineers, R&D engineers and production supervisors in development of validations, qualifications, policies and programs. Perform process validations and equipment qualifications as required. Participate in developing necessary quality policies, manufacturing procedures, and inspection procedures to ensure the production and inspection of a quality product. Participate in developing programs or projects that enhance the quality of the product and improve the production inspection of a product. Assist in the implementation, compliance and maintenance of FDA, ISO9000, ISO 13485, Canadian and European MDD requirements. Other responsibilities: Perform Internal Quality Audits as assigned. Provide support for the equipment calibration and preventative maintenance programs. Review Engineering Change Order (ECO) requests as needed. Review of manufacturing processes to include determination of the necessity of process validation. Provide problem solving support to functional departments. Interact with external vendors regarding product concerns, vendor systems and operations concerns. Provide input into which type of equipment to purchase to satisfy inspection requirements. Review sterilization validation protocol development and maintenance. Review of sterile run data from contract sterilizer. Provide QA support to product development teams for internal, as well as OEM products. Provide ongoing quality support to OEM customers. Perform other related tasks as requested or assigned. Qualifications required: Four-year college degree in Engineering and 5+ years minimum experience in a manufacturing environment at a medical device company. Knowledge of FDA, ISO9000, ISO 13485, Canadian and European MDD requirements. Knowledge of medical manufacturing setting and MRP. Knowledge of basic mechanical testing and material properties. Well developed organizational and problem solving skills. Good communication and personal skills. Knowledge of Windows-Word, Excel, Access. Knowledge of Value Stream

Job Title: Quality Engineer Company: K & W Medical Specialties Location: Westfield, PA Description: K&W Medical specialties a division of MedPlast Group, one of the nations pre-eminent medical molding manufactures, is seeking a Quality Engineer for our Westfield PA facility. We are located in middle of the gorgeous PA Wilds (www.pawilds.com)and might be the perfect match for someone who absolutely loves the great outdoors! The position will assist engineering, inspection and production personnel by designing and implementing the necessary tools, gauges, statistical support, and training required to assure the production of quality products. Key Responsibilities include: Participating in the design process for new products; Reviews and approves design for quality / reliability requirements; Develops and documents quality plans for new products and for in-process; Approves product and process changes; Assists in performing process validation/capability; Participates in conducting internal/vendor audits; Serves as chairperson or member of Material Review Board.

Job Title: Quality Engineer Company: Location: Columbia, SC Description: For quick consideration apply here Establish and provide disciplined quality planning, improvement, and control support for organizational customer requirements spanning new product introduction through final production and delivery. • Create value by driving significant improvement in value stream metrics • Deploy the Trane quality system on a customer product line with responsibility from raw material through finished goods • Drive the voice of the customer through the value stream to support zero defect philosophy • Direct cross-functional quality improvement teams demonstrating significant improvement in key quality metrics • Lead the quality and process focus for new product introduction teams • Lead and/or collaborate on six sigma and lean manufacturing initiatives • Implement process control plans for the value stream focusing on critical to quality criteria and reaction plans • Develop, collect, analyze, and report quality statistics and measures to determine process capability, sustain process control, support problem resolution, and promote continuous improvement. Initiate and lead improvement efforts as appropriate. • Acquire, develop, and provide training in quality disciplines, tools, and techniques • Initiate and/or participate in product, process, and system audits • Maintain quality databases to establish and assure quality data integrity • Prepare progress, status, technical and other reports and records as required • Provide input to organization on Six Sigma-related opportunities • Keep current on technical developments relevant to the Trane products and processes • Implement Statistical Process Control (SPC) systems and automated data collection systems • Bachelor’s degree in engineering required. Bachelor’s degree in quality management or directly related discipline with CQE certification and 3-5 years of experience will be considered in lieu of an engineering degree. • Green Belt / Black Belt certification preferred. • Minimum 3 years of product/process development or manufacturing experience with technical knowledge and expertise in quality and/or assembly, weld/fabrication, or machining process disciplines required. • Must be able to apply quality principles, tools, and methodologies to achieve organizational results that exceed internal and external customer expectations. • Working knowledge of GD&T to establish, communicate, and confirm product requirements and specifications required. • Working knowledge of application of statistical techniques and data analysis for capability studies, process control, and improvement-related decisions and actions required. For quick consideration apply here

Job Title: CALLING ALL QUALITY SYSTEMS ENGINEERS! Company: Bucyrus International, Inc. Location: Milwaukee, WI Description: Are you a Quality Systems GURU? Are you passionate about process? If you're looking for a great opportunity, come work at Bucyrus and put a quality stamp on your career! The Quality Systems Engineer will support existing and create new quality systems which include supporting activities of system definition, procedure development, implementation scheduling, training, system implementation, and internal auditing of same. Develop and administer the Bucyrus International Quality System to ensure that product quality and reliability conform to our standards and meet the demands of our customers. JOB FUNCTIONS : Provide input and recommendations to management on business process and procedural system improvements, including current ISO 9001 requirements. Review trends; track root cause of problems, and coordinate corrective and preventive actions. Manage the Discrepancy System and publish required reports. Facilitate an environment of continual improvement in the quality system by interacting with representatives from all functional groups, encompassing, but not limited to manufacturing, production, purchasing, information technology, and quality management to review organizational procedures and processes, including current ISO 9001 requirements. Promote the use of existing and develop new applications to reduce non-value-added activities in all facets of the business. Provide ERP application support to manufacturing, quality, production, information technology, scheduling and other organizational entities as required. Evaluate and develop improved quality assurance techniques for the control of quality. Monitor the total quality management system to determine overall effectiveness by conducting internal departmental quality audits and external quality audits of proposed and active suppliers. Develop and administer support on Total Quality Management related issues such as; inspection techniques, processing procedures, inspection costs versus benefits; etc., with customers, suppliers, engineering, field service, quality control; etc. Review sales inquiries to ensure that the quality requested is definable and attainable, assure that the Company understands the customer’s expectations, and determine whether the quality requirements can be satisfied.

Job Title: Quality Engineer Company: Executive Consulting, Inc. Location: Milwaukee, WI Description: Position Description A Milwaukee based manufacturing company is seeking a QC Engineer on 1st shift. Responsibilities: Responsible for ensuring the quality systems are maintained in accordance with the TS16949 standards and specific automotive requirements and reviewed annually. Will recommend, develop, implement and audit systems, procedures and changes. As an APQP and PPAP team leader, develop Process Flow Diagram, Process FMEA, Control Plan, operation and inspection instructions and procedures. Serve as a liason between the customer and the company throughout the APQP process from initial design review to successful PPAP submission. Respond to, research, determine root cause, develop and implement corrective actions for customer complaints. Qualifications: Proficient in all quality application tools including SPC, APQP, PPAP (process flow, FMEA, Control plans, Gage R&R, Capability analysis), DOE, ISO9000, and TS16949 requirements. Must have experience developing corrective actions utilizing the 8D methodology. Must be analytical and possess a strong aptitude for DETAIL. Minimum 1-3 years experience in Quality Engineering (certified internal auditor a plus). Proven ability to tackle projects independently. Highly evolved communication skills (verbal, written, computer). Must have experience developing, implementing and auditing effective quality procedures and processes. Must have good customer relations and communication skills. Must be “change agent” and thrive in a fast paced manufacturing environment. Knowledge of AS9100, implementing SPC software, six sigma, lean, internal auditing, team leading and facilitation are all desired but we are very willing to train the right candidate. Education Requirements: Bachelor degree in a Science or Engineering discipline. Contact Information Kristina Mowers Register to View f Register to View Register to View *** when applying say you found this position on WisconsinJobNetwork.com ***

Job Title: Quality Engineer Company: New Hampshire Ball Bearings Location: Los Angeles, CA Description: New Hampshire Ball Bearings, Inc., an established and respected manufacturer of precision bearing products, has an immediate position in Chatsworth, CA . NHBB is seeking a Quality Engineer. The ideal candidate is very detail oriented, analytical and is driven to be a problem solver to ensure quality standards are met. The candidate must have at least 5 years of experience in Quality Assurance/Quality control discipline in a manufacturing environment, preferably in metal turning or grinding applications. In addition, the candidate will posses excellent verbal and write communication skills. The person should be a team player and a self-starter with a hands-on attitude to work in our manufacturing shop environment! This position is responsible for ensuring product quality standards throughout the development and application of basic and advanced quality control methods and techniques. Job overview: Performs Customer PO / Contract Review Performs Customer Specification Review Manages the Internal Auditing Program Manages the Customer and 3rd Party QMS audits Quality Planning: Reviews and approves Assembly Inspection Work Orders Customer interface Other duties Job requirements BS ME preferred. 4 year technical degree 5 years of experience- Manuf. in Quality/Quality Control Proficient on MS Office; Word, Excel and Access and any statistical programs Proficient on ISO 9001:2000/ AS9100 In addition to a challenging position, we offer an excellent starting salary with a very comprehensive benefits package. NHBB also offers a monthly incentive bonus program. Benefits begin on the first of the month, following employment and they include: Medical, Dental, Vision, LTD, 401k, company paid Pension Plan, Vacation and other benefits. Please mail or FAX resume with salary history and requirements to NHBB, Inc., ATT: HR Dept. Ref: QE-JC-01, 9700 Independence Ave. , Chatsworth, CA 91311-4373 . FAX Register to View or E-mail: Register to View An Affirmative Action/EEO Employer

Job Title: Quality Engineer - manufacturing/ FMEA/ kaizen 60-90 K/yr Company: Location: Greenville, SC Description: Manufacturing Quality Engineer - Greenville, SC A leading precision machining and manufacturer has an immediate opening for a Manufacturing Quality Engineer to work in their northwest, SC location. Candidate must have at least 5 years experience in a manufacturing or machine shop environment as well as a BS Degree in Manufacturing Technology or equivalent. A solid understanding of blueprint reading, geometric dimensioning and tolerances, statistical process control, visual inspection and mechanical measuring tools will be necessary. In addition, candidate must have exposure to FMEA, Root Cause Analysis and Continuous Improvement and be familiar with ISO 9001-2000 and AS9100. Some of the responsibilities include preparing technical documents and qualification packages for delivery to customer; develop and maintain a data management program that assures control of specifications, standards and drawings; lead the Material Review Board (MRB) to manage and resolve discrepant material issues; lead Root Cause Analysis and problem solving activities; and other continuous improvement (Kaizen). This is an excellent opportunity to join a leading organization. A competitive salary based on experience, along with very comprehensive benefits and 401K and tuition reimbursement are available for the right candidate. Questions you will be asked: • What is your educational background including all Degrees and Certifications obtained? • Describe your experience in the manufacturing - welding, or machining industry including number of years. • .Do you have experience with blueprints and geometrical dimensioning and tolerances? Describe including number of years. • Describe your experience in: FMEA, Root Cause Analysis, and Continuous Improvement. • What experience do you have with ISO 9001-2000 and AS9100? What industries have you worked in? This Job is located in Greenville, SC -> United States See over 1,000 Power Plant / Energy Jobs on ThinkEnergyGroup.com. Related Words: quality, quality assurance, quality, qa, qc, statistical process control, spc, total quality management, tqm, spc, statistical process control, kaizen, iso 9000, iso 9001-2000, continuous improvement, six sigma, machining, power generation, as 9100, fmea, failure analysis

Job Title: Senior Quality Engineer - Circuit Card Assemblies Company: Location: Jackson, MI Description: You will perform as the Senior Quality Engineer and will be involved in developing processes for inspection of circuit card assemblies, process control auditing, receiving inspection, first article inspection of assemblies, SPC data collection, and return material authorization process coordination. This position will also lead/participate in continuous improvement activities such as Lean, Kaizen and Six Sigma.