As a Quality Manager, you will provide leadership to our Quality Control team and oversee all incoming and in-process quality inspections. You will oversee the maintenance of quality records following existing Standard Operating Procedures, and will drive continuous improvement and efficiency while also maintaining our quality standards.
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, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers 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.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
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.