As a member of Penumbra’s internal audit team, you will help ensure that the company’s lifesaving products meet the highest standards for safety and performance, while also promoting a strong culture of quality throughout the organization. In this role, you will communicate and carry out internal quality goals and assess Penumbra’s Quality Management System for compliance with relevant standards and regulations. You will also support logistical planning for training select internal groups on a range of quality auditing topics.

What You’ll Work On
• Take part in internal quality system audits, including creating plans and reports, leading opening and closing meetings, gathering and analyzing data, and offering input on compliance.
• Help create audit plans for specific areas by referencing SOPs and coordinating schedules.
• Organize audit opening meetings based on the established audit plan, coordinate audit schedules, and participate in discussions about the audit process and experience.
• Help produce metrics that measure internal audit performance and support improvement efforts.
• Stay informed about industry expectations and trends related to quality compliance in the medical device field.
• Assist with reviewing audit responses, corrective actions, and effectiveness checks.
• Follow up with audit response owners to ensure timely submission of required responses.
• Coordinate training sessions and webinars on key quality topics and upcoming regulatory or standards changes.
• Maintain documentation supporting the internal audit program.
• Assist in writing SOPs and work instructions and in completing engineering change orders.

What You Contribute
• A bachelor’s degree, preferably in life sciences or engineering, with 3+ years of quality systems experience in a regulated medical device or pharmaceutical setting, including at least 1 year of auditing experience, or an equivalent combination of education and experience.
• Lead Auditor certification is preferred.
• Experience in the medical device, pharmaceutical, biotech, or other regulated industries.
• Knowledge of FDA 21 CFR 820, ISO 13485, the EU Medical Device Directive (93/42/EEC), MDR, and MDSAP.
• Strong verbal, written, and interpersonal communication skills.
• Excellent accuracy and attention to detail.
• Proficiency with MS Word, Excel, and PowerPoint.
• Strong organizational skills and the ability to manage multiple projects at once.

Working Conditions
Work may take place in office, production, warehouse, laboratory, and controlled environments. Must be willing and able to work on site. Business travel may range from 0% to 10%. There may be potential exposure to blood-borne pathogens. The role requires occasional lifting of up to 15 pounds. You must be able to move between buildings and floors, remain seated and use a computer or office equipment for extended periods, read and create documents and spreadsheets, access office supplies or files, and communicate effectively with employees at all levels.

Annual Base Salary Range: $75,000–$145,000 per year
A competitive compensation package is offered, including benefits and equity when applicable. Total compensation will vary based on qualifications, skills, competencies, and location.

What We Offer
• A collaborative team environment where learning is continuous and strong performance is recognized.
• The chance to contribute to groundbreaking treatments for some of the world’s most serious diseases.
• A comprehensive benefits package for eligible employees, including medical, dental, vision, life, AD&D, disability insurance, a 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays, at least fifteen days of annual vacation (increasing with tenure), and paid sick leave as required by law.

Penumbra, Inc., based in Alameda, California, is a global healthcare company focused on developing innovative therapies. The company designs, produces, and markets unique products addressing complex medical challenges in markets with significant unmet needs. Penumbra sells its products to hospitals and healthcare providers primarily through a direct sales force in the United States, most of Europe, Canada, and Australia, and through distributors in select international regions. The Penumbra logo is a registered trademark of Penumbra, Inc.

Qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military status, or any other characteristic protected by law.

California residents should refer to Penumbra’s Privacy Notice for California Residents. Additional information regarding Penumbra’s commitment to equal employment opportunity can be found in Penumbra’s AAP Policy Statement.