Mgr II Qlty & Reliability Engineering

Responsibilities: <ul><li>Manages plant quality staff across quality systems and product quality.</li><li>Oversees the quality and documentation system and quality records program.</li><li>Manages QMS processes for management review, CAPA, regulatory agencies, customer and internal audits.</li><li>Manages and provides resources for new product development, quality engineering, inspection, measurement,and test, complaint handling, non-conforming product and MRB resolution.</li><li>Ensures compliance to FDA QSR, ISO, MDD and other applicable requirements.</li><li>Site Management Representative for the TEM quality system.</li><li>Ensure product safety, reliability and quality through the effective use of quality planning, risk analysis,statistical methods and process controls.</li><li>Provides sales and marketing support in explaining quality system and regulatory compliance capability tocustomers.</li><li>Contributes with the strategic Site team effort to accomplish results as needed</li><li>Provides leadership in the continuing evolution, improvement, and efficiency of the quality function.</li><li>Develops quality personnel to assure continuity and personal growth.</li><li>Understands and complies with all company rules and regulations.</li><li>Builds a Safe and Inclusive environment</li></ul> Requirements: Qualification &amp; Experience: <ul><li>10 years or more in a quality function with 5 years or more in management position.</li><li>BS/BA degree with a scientific/engineering emphasis required.</li><li>Leadership skills</li><li>Technical discipline or quality professional training.</li><li>Statistical techniques, metrology, and process analysis training.</li><li>Quality system design and implementation experience.</li><li>Lead and supportive on external audits.</li><li>Risk management .</li><li>Regulatory requirements and reporting responsibilities.</li><li>Supply chain development and management.</li><li>Strong analytical skills and attention to detail.</li><li>Excellent interpersonal and written communication skills.</li><li>Demonstrated ability to effectively organize, prioritize and accomplish multiple tasks, make decision and solveproblems independently.</li><li>A thorough knowledge of 21 CFR and ISO 13485.</li><li>Commitment to ethical conduct and responsibility.</li><li>Experience with MS Word, Excel, Project Management and Analytics software</li></ul>

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Mgr II Qlty & Reliability Engineering

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Mgr II Qlty & Reliability Engineering

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