Director, Quality Engineering/Site Leader
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Must Have: Minimum Requirements
• B.A./B.S. in Engineering, Scientific, or related field required
• Master’s degree/MBA preferred
YEARS OF EXPERIENCE
• 10+ years of relevant experience with increasing scope and responsibility
SPECIALIZED KNOWLEDGE REQUIRED
• Minimum of 7+ years’ people management experience with proven ability to lead and motivate teams
It would be ideal if you also had the following experience:
Track Record: Proven track record of accomplishments and innovation establishing progressive quality organizations and programs; in-depth knowledge and expertise in leading-edge quality programs and all applicable federal and international regulations
Business Savvy, Solution-oriented “Architect”: High-energy, accountable and forward-looking; able to see larger business picture to identify and diagnose problems and craft solutions.
Culture Creation: Dynamic individual with the ability to shape culture and drive quality ownership and stewardship across all functions through building a comprehensive, best-in-class quality organization and strategy to align with business objectives.
Strategic Thinker/Change Agent: Persuasive individual with the ability to work at all organizational levels, including site leadership, to educate and gain buy-in for all programs and initiatives.
Coach & Captain: Effectively challenge and influence others functional leaders to “own” implementation of quality vision and strategies; must be an approachable and trusted confidant, able to encourage confidence to receive ‘unfiltered truth’ about potential problems at all levels; lead and manage quality function and staff, as well as peers on programs and initiatives.
Drive/“Get it done” Attitude- Must be a hands-on leader and practical thinker, able to identify and devise realizable solutions and roll-up sleeves to get things done; able to identify and alleviate potential hurdles to achieving objectives, successfully manage people and projects, both directly and through influence.
Medical capital equipment including software
Strong product development and risk management experience
ASQ Certified CQA, CQE, CQM
RAPS Certified
Deep knowledge and effective working with both domestic and international regulations and agencies including FDA QSR, ISO 13485/9001, MDD, CMDCAS, SFDA, JPAL MHLW, ANVISA and other regulations/agencies.
Australian Medical Device Regulations Department of Health, Therapeutic Goods Administration (TGA) requirements set forth in Therapeutic Goods Regulations 1990, Therapeutic Goods Act (Medical Devices) Regulations 2002, Therapeutic Goods Amendment Regulations 2010, and Australian Regulatory Guidelines for Medical Devices (ARGMD) 2011
Brazilian Good Manufacturing Practices RDC No. 16/2013, Technical Regulation of Good Manufacturing Practices of Medical Devices and In Vitro Diagnostic Devices Requirements for Proof of GMP for Registration Processes RDC 15/2014 National Health Surveillance Agency - ANVISA (Agência Nacional de Vigilância Sanitária).
Continuous quality improvements are built into our “Quality Begins With Me” culture.
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