Senior Supplier Quality & Compliance Analyst
Penumbra
Opportunity published from Lever · applications stay with the original hiring source.
About the opportunity
- As a Senior Supplier Quality & Compliance Analyst, you will manage external suppliers through audits and periodic evaluations.
You will lead ongoing supplier quality activities and agreements, act as lead auditor during supplier audits, and support supplier development initiatives in alignment with Procurement and Supplier Quality Engineering to improve quality and meet business objectives.
- You will organize and facilitate the external supplier audit program, analyze data, coordinate audit logistics, and ensure documentation meets QMS requirements.
You will independently analyze supplier compliance, determine audit findings, develop strategic audit plans, review supplier procedures, and author comprehensive audit reports with well-founded recommendations.
Key responsibilities
- Organize and facilitate the external supplier audit program by analyzing data, coordinating audit logistics, and ensuring documentation is completed per QMS requirements.
- Act as auditor or lead auditor within the designated auditing team, develop strategic audit plans, and conduct professional audits reviewing supplier procedures against compliance requirements.
- Author supplier audit reports following QMS requirements, draw conclusions regarding compliance status, present potential findings for leadership review, and run closing meetings.
- 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 and maintain the Approved Distributor List (ADL).
- Proactively identify and collaborate with suppliers to resolve day-to-day quality and compliance issues, and own, manage, and drive NCRs and CAPAs as necessary.
- Develop, recommend, and implement improvements to supplier quality procedures, work instructions, and controls, and manage and release ECOs.
- Mentor junior Supplier Quality & Compliance Analysts and interface with internal departments, customers, and suppliers on quality-related issues.
Qualifications
- A Bachelor's degree in science or a related field, with 7+ years of quality systems experience preferably in a medical device environment, or an equivalent combination of education and 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.
- Familiarity with current Good Manufacturing Practices within a medical device environment or equivalent industry.
- Strong oral, written, and interpersonal communication skills, along with proficiency in MS Word, Excel, and PowerPoint.
- Willingness and ability to work on-site in general office, production, warehouse, laboratory, and controlled environments, with 0% to 25% business travel and ability to lift up to 15 pounds.
Nice to have
- Training and experience in performing internal and external audits
- ASQ CQA certification
Annual Base Salary Range
- $113,000 - $150,000 / year
- Competitive compensation package
- Benefits program
- Equity program, when applicable
Job details
- Location: On-site (General office, production, warehouse, laboratory, and controlled environments)
- Travel requirements: 0% to 25% business travel
- Compensation: $113,000 - $150,000 / year (Annual Base Salary Range) plus benefits and equity program when applicable
Application: UpVagas lists this opportunity from the hiring company or its recruitment platform. The application is completed at the original source.
Key details from the source
- You will evaluate supplier corrective-action responses, manage the supplier audit schedule, maintain the Approved Distributor List (ADL), lead the preparation and update of Supplier Quality Agreements, and own NCRs and CAPAs.
Full listing
UpVagas condensed repetitive or legal boilerplate to make this page easier to read. The original hiring source contains the complete job description.
Source transparency. UpVagas organizes information provided by the company or recruitment source. Always review the original listing before submitting personal information.
