Compliance Engineer

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over 2 years old

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As a member of Penumbra’s compliance team, you will play a key role in ensuring that Penumbra's lifesaving products meet the highest standards of safety and effectiveness, and in continuously improving our Quality Management Systems processes. To do this, you will lead and utilize process improvement methodologies and risk-based principles to identify opportunities, plan improvements, execute those plans, and then follow up to ensure a proactive state of compliance.

What You'll Work On

  • Lead, communicate, and bridge the gap between software quality and quality compliance to ensure requirements within the QMS are met and/or preserved.
  • Manage and coordinate the generation and revision of processes and procedures in support of quality system requirements.
  • Act as SME on ECOs related to QMS updates in support of product software quality.
  • Identify opportunities for improving the current programs, processes, and procedures as may be required by changes in regulatory requirements, business plans or other changes.
  • Support post market quality system activities (e.g., complaints, NCR, CAPA).
  • Support internal audits and regulatory/ISO inspections.
  • Interpret and provide guidance on applicable and upcoming federal and international regulations.
  • Use strong communication, presentation, and influential management skills to work effectively across functions as a model and champion for quality.

    • What You Bring

  • The desire to work and learn in a dynamic, fast-paced environment.
  • A Bachelor's degree in Engineering, Science, or a related field plus 5+ years of related experience in the fields of quality, biomedical, life / physical sciences, engineering, or equivalent combination of education and experience.
  • Technical writing proficiency (e.g., protocols, analytical reports, ECOs, SOPs, Work Instructions).
  • Understanding of FDA regulations, and ISO 13485:2016, IEC 62304, and ISO 14971 desired
  • Experience working with a variety of quality and process improvement tools required.
  • Project management skills desired.
  • Excellent verbal, written, and interpersonal communication skills
  • Demonstrated ability to work cross-functionally to solve problems and drive projects to completion
  • Solid analytical and decision-making ability and leadership skills


    • 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.