Senior Supplier Quality & Compliance Analyst

Penumbra, Inc.

. Manage external suppliers through supplier audits and periodic evaluations .

Posted 10/14/2026full-timeAlameda • California • United StatesSenior💰 $113,000 - $150,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing supplier audits and compliance within the medical device industry, with a strong focus on quality systems, statistical analysis, and regulatory requirements. Proficient in developing audit plans, conducting evaluations, and mentoring junior analysts to enhance supplier quality.

Highest-signal resume keywords

Supplier Audit ManagementQuality Systems ExperienceStatistical MethodologiesQSR and ISO ComplianceASQ CQA Certification

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Supplier AuditsData AnalysisAudit ReportingCorrective Action PlansQuality Management SystemsStatistical AnalysisRegulatory ComplianceSupplier Performance EvaluationDocument ControlProcess Improvement

Soft Skills

Interpersonal CommunicationAttention to DetailTime ManagementMentoringProblem Solving

Tools & Technologies

MS WordMS ExcelMS PowerPoint

Certifications & Qualifications

ASQ CQA Certification

Industry Keywords

Medical Device Quality ComplianceGood Manufacturing PracticesSupplier Quality EngineeringExternal Compliance RequirementsAudit Logistics

About the role

Key responsibilities & impact

Manage external suppliers through supplier audits and periodic evaluations
Organize and facilitate the external supplier audit program, including data analysis, audit logistics, and QMS documentation
Analyze supplier compliance and determine or recommend audit findings and follow-up actions
Act as auditor or lead auditor during supplier audits
Develop strategic supplier audit plans and align audit scope with Supplier Quality Engineering
Assess supplier changes, previous audits, and supplier performance
Review supplier procedures against internal and external compliance requirements
Author supplier audit reports, summarize audits, draw compliance conclusions, and provide recommendations
Lead closing meetings and audit follow-up activities
Evaluate supplier corrective-action responses and determine whether evidence, remediation, or escalation is required
Manage the supplier audit schedule
Lead preparation, review, and update of Supplier Quality Agreements
Maintain the Approved Distributor List (ADL)
Resolve day-to-day supplier quality and compliance issues
Maintain records supporting Supplier Quality
Own, manage, and drive NCRs and CAPAs
Improve 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 internal departments, customers, and suppliers on quality-related issues
Monitor industry requirements and trends related to medical device quality compliance
Communicate timely with suppliers and distributors
Mentor junior Supplier Quality & Compliance Analysts

Requirements

What you’ll need

Bachelor's degree in science or related field, with 7+ years of quality systems experience, preferably in a medical device environment, or 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
Familiarity with current Good Manufacturing Practices within a medical device environment or equivalent industry
Proficiency with MS Word, Excel, and PowerPoint
Training and experience in performing internal and external audits preferred
ASQ CQA certification preferred
Ability to manage multiple complex priorities within demanding timeframes with attention to detail
Strong oral, written, and interpersonal communication skills
Willingness and ability to work on site
Ability to travel for business, potentially 0% to 25%
Ability to lift and move up to 15 pounds
Ability to move between buildings and floors
Ability to remain stationary and use a computer or standard office equipment for extended periods
Ability to read, prepare emails, and produce documents and spreadsheets
Ability to move within the office and access file cabinets or supplies
Ability to communicate and exchange accurate information with employees at all levels

Benefits

Comp & perks

Medical, dental, vision, life, AD&D, short-term disability, and long-term disability insurance
401(k) with employer match
Paid parental leave
Eleven paid company holidays per year
Minimum of fifteen days of accrued vacation per year, increasing with tenure
Paid sick time in compliance with applicable law(s)
Equity program, when applicable
Collaborative teamwork environment
Learning opportunities
Performance-based rewards