The Director, Quality Engineering is responsible for Quality teams, QA & QC, involved in producing and supporting our products. This role has responsibility for all quality operation activities related to manufacturing of Endologix products globally and for working with peer functions in Operations, Supply Chain, R&D, and Regulatory to identify quality engineering, assurance, and control strategies to ensure the highest quality standards for our products. In addition, this role is a key leader in the problem-solving process for issues affecting product and service quality.
A Bachelor’s degree in a technical discipline is required.
Master’s Degree preferable
Minimum of eight to ten (8-10) years of Quality Engineering experience in the Medical Device.
Strong communication and people management capabilities. Ability to lead change through education, sales, and negotiation skills.
Proven managerial and leadership skills leading to consistent improvement in team performance, process capability and product quality. Preferred experience managing multiple sites.
ASQ Certification in any of the Quality Disciplines strongly desired.
Lean or Six Sigma training strongly desired.
Training on regulated industry quality management.
Demonstrated experience and success in the application of Quality Management principles
Demonstrated experience and application of US and International Medical Device regulatory schemas and standards, such 21 CFR 7, 803, 806, and 820, EU Medical Device Regulation, Medical Device Single Audit Program (MDSAP)
Excellent analytical and decision-making skills.
Experience in a fast-paced remedial environment leading to rapid growth.
Demonstrated experience in communicating successfully with regulatory agencies such as: FDA, PMDA, MHLW, EU
Ability to travel between Milpitas and Santa Rosa on regular basis, with occasional travel to Irvine location.
Compensation: $190,000 to $215,000 annual salary, plus Bonus and Equity potential
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