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 Management System against applicable standards and regulations. You will also assist in the logistics for training of select internal groups on a variety of quality auditing topics.
What You’ll Work On
• Participate in quality system internal audits including development of plans, reports, opening and closing meetings, collection, and analysis of data; provide input regarding compliance status.
• Assist in the development of plans for the specific audited area, referencing the SOP and connecting with coordinating with schedules.
• Schedule the audit opening meeting with the established audit plan and coordinating the audit schedule meetings as well as participating in the overview of the audit experience and process.
• Support the generation of metrics to measure internal audit compliance success and support improvement opportunities.
• Stay current on industry requirements and trends related to quality compliance in the medical device industry.
• Assist with the review of internal audit responses, corrective action, and effectiveness checks.
• Follow up with responses with internal audit response owners to ensure responses are received in a timely manner.
• Coordinate training sessions and webinars for relevant quality topics and upcoming changes to standards or regulations.
• Maintain records that support the internal audit program.
• Assist in writing standard operating procedures and work instructions and performing 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 environment with at least 1+ year in quality system auditing, or an equivalent combination of education and or demonstrated experience.
• Lead Auditor certification preferred.
• Medical device, pharmaceutical, biotech, or other regulated industry experience
• Knowledge of FDA 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), MDR and MDSAP
• Excellent oral, written, and interpersonal communication 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, production, warehouse, laboratory, and controlled environments. Willingness and ability to work on site. May have business travel from 0% to10%. 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: $75,000 - $145,000 / 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.