Internal Quality Auditor

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about 1 year old

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As a member of Penumbra’s internal audit team, you will play a key role in ensuring that Penumbra's lifesaving products meet the highest standards of safety and effectiveness, and in instilling a quality mindset throughout the company. To do this, you will communicate and implement quality objectives internally and evaluate Penumbra’s Quality System against applicable standards and regulations.

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.
  • Bachelor's degree in Engineering, Science, or a related field with a minimum of 5+ years of quality systems experience in medical device industry with at least 2 years in quality system auditing, or an equivalent combination of education and experience.
  • In depth knowledge of FDA’s 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), MDR (2017/745), and MDSAP requirements.
  • 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 part of the team 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.
     
    If you reside in the State of California, please also refer to Penumbra’s Privacy Notice for California Residents.