Job Details
Posted 29 April, 2026
Job Id: 627478
Quality Assurance, Specialist 3
Job Description
Job Summary
The Supplier Quality Analyst is responsible for ensuring that suppliers of materials, components, and services used in medical devices consistently meet quality, regulatory, and risk requirements. This role supports compliance with FDA Quality System Regulation (21 CFR 820), ISO 13485 through supplier performance monitoring, corrective action management, and risk-based supplier controls.
Key Responsibilities
- Manage and maintain supplier qualification, monitoring, and re-evaluation activities in accordance with 21 CFR 820.50 (Purchasing Controls) and ISO 13485.
- Monitor supplier quality performance using KPIs such as defect rates, corrective action trends, and supplier risk levels.
- Maintain approved supplier lists (ASL) and supplier quality records per document control requirements.
- Issue, track, and evaluate Supplier change requests.
- Escalate supplier quality risks and support remediation and improvement plans.
- Review and support supplier-initiated or internally driven changes that may impact product quality or compliance (materials, processes, manufacturing location).
- Collaborate with Engineering and Regulatory Affairs to assess supplier changes requiring validation, verification, or regulatory impact evaluation.
- Provide supplier quality input for management reviews and quality metrics.
- Ensure supplier quality documentation is accurate, complete, and maintained in the electronic Quality Management System (eQMS).
- Ensure supplier activities comply with internal procedures, regulatory requirements, and quality system expectations.
Required Qualifications
- Bachelor’s degree in Engineering, Quality, or a related field; or equivalent experience.
- 2-5 years of experience in Supplier Quality, Quality Assurance, or Manufacturing within a medical device or other regulated environment.
- Working knowledge of 21 CFR 820, ISO 13485, and supplier control requirements.
- Proficiency in Microsoft Excel and data analysis.
Key Skills & Competencies
- Strong understanding of regulated quality systems
- Analytical, detail-oriented problem-solving mindset
- Clear written and verbal communication
- Ability to influence suppliers and internal stakeholders
- Strong organizational and time-management skills
Pay rate $35-43/hr based on skill set
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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