Senior Supplier Quality & Compliance Analyst

Regulatory Jobs; Alameda (CA); On-site; USD 113,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with employer match

Parental leave

11 paid holidays per year

15+ days accrued vacation

Paid sick time

Job summary

Penumbra, Inc., headquartered in Alameda, California, seeks a Senior Supplier Quality Auditor to organize and lead external supplier audits, analyze compliance, and drive corrective actions in a medical device setting. You will develop audit plans, review supplier performance, and manage the supplier quality documentation on site with occasional travel.

The role requires a science degree with 7+ years in quality systems, familiarity with QSR/ISO, GMP, and strong communication skills.

Qualifications

• A Bachelor's degree in science or related field is required.
• Experience in statistical methodologies and analysis.
• Working knowledge of the QSR, ISO and other applicable regulations.
• Ability to manage multiple, complex priorities within demanding timeframes.
• Familiar with Good Manufacturing Practices in a medical device environment.
• Strong oral, written, and interpersonal communication skills.
• Proficiency with MS Word, Excel, and PowerPoint.
• Training and experience in internal/external audits preferred.
• ASQ CQA certification preferred.

Responsibilities

• Organize and lead external supplier audits and ensure QMS documentation is complete.
• Analyze supplier compliance and determine appropriate audit findings and follow-up actions.
• Act as auditor/lead auditor within the auditing team on supplier audits.
• Develop strategic audit plans referencing procedures and alignment with Supplier Quality Engineering.
• Audit scope assessment and review of supplier changes and past audits.
• Conduct audit activities professionally and review procedures for compliance.
• Prepare supplier audit reports and summarize findings for leadership review.
• Evaluate corrective actions and determine need for additional evidence or escalation.
• Maintain supplier audit schedule in alignment with leadership and SQE.
• Lead preparation and updates of Supplier Quality Agreements with suppliers.
• Maintain the Approved Distributor List (ADL).
• Identify and resolve day-to-day quality and compliance issues with suppliers.
• Maintain records supporting Supplier Quality.
• Own NCRs and CAPAs as needed to support quality compliance.
• Develop improvements to supplier quality procedures and controls; release ECOs for process improvements.
• Interface with internal departments, customers, and suppliers on quality issues.
• Stay current on industry requirements and trends in medical device quality compliance.
• Communicate with suppliers and distributors in a timely manner.
• Mentor junior Supplier Quality & Compliance Analysts.

Skills

Statistical analysis

QSR & ISO knowledge

Auditing

Multi-priority management

GMP knowledge

Communication skills

MS Word

MS Excel

PowerPoint

Documentation skills

Education

Bachelor's degree in science or related field

ASQ CQA certification

Tools

MS Word

MS Excel

PowerPoint

Job description

What You’ll Work On

• Organize and facilitate the external supplier audit program by analyzing data, coordinating audit logistics, and ensuring documentation is completed per QMS requirements
• Independently analyze supplier compliance against applicable requirements and determine or recommend appropriate audit findings and follow-up actions.
• Act as auditor/lead auditor within the designated auditing team on supplier audits.
• Develop strategic audit plans for suppliers selected for audit, referencing applicable procedures and aligning with Supplier Quality Engineering on audit scope.
• Engineering on audit scope. Assess supplier changes and review previous audits and supplier performance.
• Conduct audit activities in a professional manner. Review supplier procedures against internal and external compliance requirements. *
• Author supplier audit reports following QMS requirements and provide a summary of the audit. Draw conclusions regarding compliance status and present potential findings for leadership review. Provide well-founded recommendations for improvement. Run closing meetings and review process for audit follow-up activities.
• Evaluate the adequacy of supplier corrective-action responses and determine whether additional evidence, remediation, or escalation is required to ensure any nonconformances are sufficiently addressed.
• Manage the development and maintenance of the supplier audit schedule in alignment with leadership and Supplier Quality Engineering to support ongoing quality improvement efforts and business objectives.
• Lead the preparation, review, and update of Supplier Quality Agreements by developing criteria, ensuring alignment with regulatory standards, and collaborating with suppliers to address quality issues.
• Maintain the Approved Distributor List (ADL)
• Proactively identify and collaborate with suppliers to resolve day-to-day quality and compliance issues and address potential issues before they elevate.
• Maintain records that support Supplier Quality.
• Own, manage, and drive NCRs and CAPAs, as necessary, in support of Supplier Quality Compliance functions.
• Develop, recommend, and implement improvements to supplier quality procedures, work instructions, and controls based on audit trends, compliance risks, and supplier performance data. Manage and release ECOs to support process improvements and resolve supplier-related issues.
• Interface with other internal departments, customers, and suppliers on quality-related issues
• Remain current on industry requirements and trends related to quality compliance in the medical device industry.
• Responsible for timely communication with suppliers and distributors.
• Mentor junior Supplier Quality & Compliance Analysts.

What You Contribute

• A Bachelor's degree in science or related field, with 7+ years of quality systems experience preferably in a medical device environment, equivalent combination of education and /or demonstrated experience.
• Experience in statistical methodologies and analysis
• Working knowledge of the QSR, ISO and other applicable regulations and laws
• Ability to manage multiple, complex priorities within demanding timeframes with attention to detail.
• Familiar with current Good Manufacturing Practices within a medical device environment (or equivalent industry).
• Strong oral, written, and interpersonal communication skills
• Proficiency with MS Word, Excel, and PowerPoint
• Training and experience in performing internal and external audits preferred
• ASQ CQA certification preferred

Working Conditions

General office, production, warehouse, laboratory, and controlled environments. Willingness and ability to work on site.May have business travel from 0% to25%. 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: $113,000 - $150,000 / 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, 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.