Sr Manufacturing Operations QA Director
Company | Medtronic |
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Location | Orange, CA, USA, Irvine, CA, USA |
Salary | $211200 – $316800 |
Type | Full-Time |
Degrees | Bachelor’s |
Experience Level | Senior, Expert or higher |
Requirements
- Bachelor’s degree required.
- Minimum of 15 years of relevant Manufacturing Quality / Engineering experience with 10+ years of managerial experience, or an advanced degree with a minimum of 13 years of relevant Manufacturing Quality / Engineering experience with 10+ years of managerial experience.
Responsibilities
- Lead both manufacturing sites towards excellence in product quality and operational excellence, fostering a culture that prioritizes quality and puts patients first.
- Develop and implement comprehensive training programs to enhance team skills and capabilities.
- Ensure manufacturing operations are inspection-ready every day by maintaining rigorous quality standards and documentation practices.
- Collaborate cross-functionally with colleagues in Global Operations & Supply Chain, Strategy & Technology, Supplier Quality, Micro & Sterilization Assurance Regulatory Affairs, R&D, and others to drive Quality and Enterprise Operations strategies.
- Oversee the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and standards.
- Lead audit and inspection preparation, resolving findings, and liaising with auditing groups and inspectors.
- Create a culture of continuous learning across areas of responsibility, identifying root causes of quality issues and institutionalizing organizational learning.
Preferred Qualifications
- Experience in Medical, Pharmaceutical or highly regulated product industry.
- DMAIC Lean / Six Sigma Certification and demonstrated experience leading DMAIC Projects.
- Demonstrated experience leading Kaizen Events and multiple Quality-related functions.
- Experience with tissue products.
- Strong leadership, change management, and transformation skills.
- Excellent communication, interpersonal, and talent management skills.