As a Compliance Engineer II and a key member of Penumbra’s compliance team, you will play a vital 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

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  Manage and coordinate the generation and revision of processes and procedures in support of software to ensure quality system requirements are met.
• 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).
• 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 Contribute

• 
  Bachelor’s degree with 3+ years of related experience in the fields of quality, biomedical, life/physical sciences, engineering, or equivalent combination of education and experience
• Medical device, pharmaceutical, biotech, or other regulated industry experience
• Technical writing proficiency (e.g., protocols, analytical reports, ECOs, SOPs, Work Instructions)
• Understanding of FDA QSRs and ISO 13485:2016
• Experience working with a variety of quality and process improvement tools required
• Project management skills
• Excellent oral, 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
• High degree of accuracy and attention to detail
• Proficiency with MS Word, Excel, and PowerPoint
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

Working Conditions

General office environment. May have business travel from 0% - 10%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 15 pounds. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Annual Base Salary Range: $73,877- $110,876 / year

We offer a competitive compensation package plus a benefits and equity program, when applicable.

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

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 for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

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, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra’s Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP-Policy-Statement.

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