What You'll Achieve:
- Coordinate and conduct Quality System internal audits
- Act as lead auditor for Quality System audits, including development of audit plans and audit reports, leading opening and closing meetings, collection and analysis of data, and drawing conclusions with regards to compliance status
- Assist in generating metrics to measure internal audit compliance success and identify improvement opportunities
- Stay current on industry requirements and trends related to compliance in device manufacturing, testing and development
- Understand and adhere to domestic and international regulatory requirements
- Write standard operating procedures, engineering change orders, and corrective/preventive action requests
- Assist with coordination of internal audit program
- Interface and collaborate with internal management on quality-related issues
- Assist with the management and improvement of Penumbra’s internal auditor program
- Mentor colleagues participating in internal audits
What you bring:
- The desire to work and learn in a dynamic, fast-paced environment.
- An Associate or Bachelor's degree in Engineering, Science, or a related field.
- Three years of quality systems/quality auditing experience in the medical device industry or an equivalent combination of education and experience.
- In-depth knowledge of FDA’s 21 CFR 820, ISO 13485, MDSAP, EU Medical Device Directive (93/42/EEC), and Canadian Medical Device Regulation (SOR/98-282).
- Lead Auditor or ASQ CQA, CBA or certification desirable.
- Excellent verbal, written, and interpersonal communication skills
- The ability to travel up to 10% time.
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.