How You'll Contribute
- Manage incoming, in-process, packaging, labeling, and engineering development inspections.
- Ensure that FDA Quality System Regulations (QSR), Medical Device Directive (MDD), and applicable ISO requirements are in place and being followed for inspection-related activities.
- Use your expert knowledge of our Quality System to formulate and carry out company directives.
- Utilize your leadership skills to supervise, coach, evaluate, and motivate a team of Quality Supervisors, Inspectors and Specialists.
- Allocate team members and material resources as needed.
- Use your strong interpersonal skills to Interface with the FDA, State agencies, and notified bodies during routine ISO audits and FDA inspections.
- Ensure that health and safety guidelines are followed.
What You Bring
- Solid analytical and decision-making ability and leadership skills.
- Experience in statistical and data analysis.
- A thorough knowledge and understanding of FDA QSRs, ISO standards, and the MDD.
- Knowledge of sterilization requirements for medical devices.
- Proficiency with technical writing of protocols, analytical reports, ECOs, SOPs, Work Instructions, and Inspection Methods.
- Practical knowledge in Statistical Process Control, Process Capability, Gage R&R, DOE, software Quality Assurance, electronic records, and risk analysis.
- Bachelor of Science degree and a minimum of 8 years equivalent combination of education and experience in the quality assurance or engineering in the life sciences industry.
- ASQ certifications for CQE, CQA, CQM, or equivalent preferred.
What We Offer
- A collaborative teamwork environment where learning is constant and performance is rewarded.
- The opportunity to be at the forefront of technology that is revolutionizing the treatment of some of the world's most devastating diseases.
- A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
PENUMBRA TODAY Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on interventional therapies. Penumbra designs, develops, manufactures and markets innovative devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Penumbra sells its products to hospitals primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.