Quality Compliance Auditor

4 weeks ago

Oakland, California, United States Penumbra Full time

As a key member of Penumbra's internal audit team, you will play a pivotal role in ensuring that the company's lifesaving products meet the highest standards of safety and effectiveness. Your expertise will be instrumental in instilling a quality mindset throughout the organization.

To achieve this, you will communicate and implement quality objectives internally, evaluating Penumbra's Quality Management System against applicable standards and regulations. Your responsibilities will also include assisting in the logistics for training select internal groups on quality auditing topics.

Key Responsibilities:

  • Participate in quality system internal audits, developing plans, reports, and providing input on compliance status.
  • Assist in developing plans for specific audited areas, referencing SOPs and coordinating schedules.
  • Schedule audit opening meetings, coordinating audit schedules, and participating in audit overview and process.
  • Support the generation of metrics to measure internal audit compliance success and identify improvement opportunities.
  • Stay current on industry requirements and trends related to quality compliance in the medical device industry.
  • Assist with reviewing internal audit responses, corrective actions, and effectiveness checks.
  • Follow up with internal audit response owners to ensure timely responses.
  • Coordinate training sessions and webinars on quality topics and regulatory updates.
  • Maintain records supporting the internal audit program.
  • Assist in writing standard operating procedures and work instructions, and perform engineering change orders.

Requirements:

  • Bachelor's degree in life sciences or engineering, with 3+ years of quality systems experience in a regulated medical device or pharmaceutical environment, and at least 1+ year in quality system auditing.
  • 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 and handle multiple 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% to 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 for an extensive period 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.

Compensation:

A competitive compensation package, including a generous benefits program and equity opportunities. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

About Penumbra:

Penumbra is a global healthcare company focused on innovative therapies. We design, develop, manufacture, and market novel products addressing challenging medical conditions in markets with significant unmet need. We sell our products to hospitals and healthcare providers primarily through our direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets.

Equal Opportunity Employer:

Penumbra is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment where all employees feel valued and respected. 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.

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