Design Quality Engineering Manager

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Job ID Number: 2013008512 Location: USA - CA - Irvine Job Description Position Summary Covidien is seeking a Design Quality Engineering Manager to provide leadership and set strategy for the Intrasaccular devices franchise. Will provide oversight of quality leads, engineers, and technicians in the development of new products and support for manufacturing and distribution of commercially-released products. Ensures that franchise activities are aligned with overall company goals and strategies. Will apply knowledge of design control principles and quality engineering techniques to positively influence the development of new products and to ensure they are developed and manufactured in accordance with regulatory and customer requirements and is responsible for developing, maintaining and improving the design control, product development and new supplier development processes. Will review and evaluate scientific and technical data as it pertains to products, product testing and lead teams to identify and solve complex product problems. Principal Accountabilities Assist quality management in setting the strategy for the Quality Organization. Supervise Quality Leads, Quality Engineers, and technicians including hiring, training, motivating, monitoring, evaluating, directing, and oversight of staff. Provide guidance to Quality Engineering staff and other personnel and ensures that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review Set strategy for the early stages of product development including but not limited to physician interaction, product engineering, competitive product testing, and prototype testing. Contributes to design input requirements from experience with previously reported problems, Covidien products, competitive devices and/or other similar products. Provide direction, oversight, and training for engineering staff to: Actively represent Quality Assurance function on product/process development teams. Lead product risk analysis teams. Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations Lead supplier quality through the design and development process. Participate in supplier selection and specification reviews with suppliers to ensure that purchased items meet Covidien specifications. Perform or oversee supplier audits as needed. Lead or participate in design reviews to evaluate designs and to help identify alternative design solutions. Create, evaluate, and validate product and process test methods. Develop master test plans that encompass design verification, design validation and process validation activities. Lead the qualification of new suppliers, new components and changes by developing and executing, in conjunction with other internal groups, a robust and complete set of requirements for such qualifications. Evaluate test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives. Supervise less senior Quality Engineers and quality technicians, including hiring, training, motivating, monitoring, evaluating, directing, and oversight of staff. Remediate legacy products and documentation. Partners with Suppliers to design, develop and qualify processes to yield quality components. Partners with Global Sourcing to assist in Supplier consolidation efforts for continuous improvement and cost-savings. Maintains a professional, ethical, and credible image with suppliers and internal functions, ensuring that this position is deemed a resource person to R&D, Purchasing, Manufacturing, and suppliers. Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Covidien specifications. Evaluates and dispositions nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements. Promotes continuous improvement in design control activities and use of quality tools with design team. Comply with applicable FDA and international regulatory laws/standards and the Covidien Code of Conduct. Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices. Represent Covidien as appropriate in FDA, notified body, internal, and other audits. Other duties as assigned or required. Requirements Experience: 6+ years engineering experience in the medical device industry (or related industry). Experience in related engineering areas, e.g. R&D, PD, Operations or Manufacturing may also be applicable if experience includes work responsibilities listed above. Previous supervisory experience required. Experience in vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, and/or guide wires preferred. Self-motivated and committed to a team approach. Strong interpersonal, organizational and project management skills. Strong oral, presentation and technical writing skills. ASQ certified Manager of Quality and Organizational preferred. Demonstrated skills in decision making – preferably across a broad spectrum of Quality Engineering responsibilities. Education: Bachelor’s Degree or higher in Science or Engineering (or related field) Job Competencies: Extensive knowledge of quality tools: Risk analysis Highly proficient in math and use of statistical techniques Six sigma Design of experiments Lean principles Root cause analysis Problem solving approaches Reading and correcting drawings Computer literate; use of word processing, spreadsheets Project management methods and tools Quality System Regulation (QSR) Medical Device Directives (MDD) ISO procedures / Other Nation & International Standards FDA requirements and guidance Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) Use of various tools, including microscopes, calipers, and other inspection equipment Knowledge of sampling methods Recognize problems and proactively take corrective measures Physical Requirements: Standing Sitting Walking Stairs Travel by air, rail, boat, and/or auto Working on parts while looking through a microscope Manual dexterity Eye/hand coordination Significant computer operation Light lifting Direct exposure to health and safety hazards associated with production materials and equipment - See more at:
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Quality Control

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