Senior Supplier Quality Auditor & Compliance Lead

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

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.