Senior Supplier Quality & Compliance Analyst
Alameda · USD 113,000-150,000 / year · 7+ years experience · Hybrid · Posted Oct 13, 2026
At a glance
- Experience
- 7+ years experience
- Workplace
- Hybrid
- Location
- Alameda
- Salary
- USD 113,000-150,000 / year · Base salary
About the role
- As a Senior Supplier Quality & Compliance Analyst, you will engage in the management of external suppliers through supplier audits and periodic evaluations of suppliers.
- The role is responsible for leading ongoing supplier quality related activities agreements, acting as lead auditor during supplier audits and supporting supplier development initiatives.
Responsibilities
- 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.
- Conduct audit activities in a professional manner and review supplier procedures against internal and external compliance requirements.
- Author supplier audit reports following QMS requirements, provide a summary of the audit, and draw conclusions regarding compliance status.
- Evaluate the adequacy of supplier corrective-action responses and determine whether additional evidence, remediation, or escalation is required.
- Manage the development and maintenance of the supplier audit schedule in alignment with leadership and Supplier Quality Engineering.
- Lead the preparation, review, and update of Supplier Quality Agreements by developing criteria and ensuring alignment with regulatory standards.
- Own, manage, and drive NCRs and CAPAs, as necessary, in support of Supplier Quality Compliance functions.
Requirements
- A 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
- 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
Preferred qualifications
- Training and experience in performing internal and external audits preferred
- ASQ CQA certification preferred
Benefits
- 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
- Minimum of fifteen days of accrued vacation per year, which increases with tenure
- Paid sick time in compliance with applicable law(s)
Workplace
- May have business travel from 0% to 25%.
Skills
- MS Word
- Excel
- PowerPoint