Director of Quality Assurance Job in San Jose 95113, California US
Director of Quality Assurance
Summary:
The candidate will report directly to the Director of RD, and indirectly to the Sr. Director of QA. This candidate will plan, execute and manage quality assurance activities for the development and commercialization activities of new products, maintaining compliance with regulatory company requirements. They will also provide QA leadership and strategic approaches, and partner with the NPD/RD, FOD, and Regulatory Operations organizations in rapid development commercialization of new products. Ensure effective technical design reviews and effective implementation utilization of quality tools within RD and new product development. Assess impact on engineering systems and makes recommendations accordingly. Build a culture of leading engineers to create effective quality engineering processes at all levels throughout the engineering organization. Guide high-level engineers in development implementation of innovative quality engineering tools, techniques and systems that will drive successful product development. Provide vision leadership in identification, design implementation of leading quality engineering systems to support entire product life cycle with focus on business results.
Qualifications:
- B.S. in a Science, Engineering, or Physical Science 12 year’s related experience is required.
- 5 years of active management experience is required. An advanced degree is preferred.
- Knowledge experience in Quality Assurance in the Medical Device environment is required.
- Previous experience in RD Quality is required. ASQ CQM and/or CQA certification is preferred.
- Six Sigma/Lean certification is preferred.
- Experience managing budgets is preferred.
- Understanding of QSR's, MDD, ISO 13485, and other international standards is required.
- Experience managing in a matrix organization is preferred.
- Up to approximately 25% international and domestic travel may be required.
If interested in this excellent opportunity, please send your resume in a word attachment to: Will@Fusion408.com
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