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Sr QA Specialist - Supplier QA Job Opening In South San Francisco – Now Hiring Insight Global


Job description

Job Description
We are seeking a Senior QA Specialist in Supplier Quality Assurance who will play a critical role in managing and improving supplier and contract manufacturer (CMO) relationships.

This person will lead efforts to qualify, monitor, and reassess suppliers—especially during design transfers and new product introductions.

This includes conducting audits, managing non-conformances, and ensuring compliance with FDA, ISO 13485, and EU IVDR standards.

You’ll collaborate closely with R&D, Supply Chain, and external partners to define supplier selection criteria, establish quality agreements, and oversee technical transfers.

This is a full-time hybrid role with an anticipated onsite presence of three days per week and approximately 30% travel, primarily domestic with occasional international visits.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.

We are an equal opportunity/affirmative action employer that believes everyone matters.

Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.

If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Skills and Requirements
• Bachelor’s degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related field
• 5+ years of QA experience in the medical device or IVD industry
• Strong expertise in supplier quality management and CMO oversight
• Deep knowledge of ISO 13485:2016, ISO 14971:2019, and IVDR (EU 2017/746) standards
• Proven experience conducting supplier audits and managing corrective actions
• Experience with design transfer and technical validations
• Ability to manage supplier qualification, monitoring, and reassessment processes
• Excellent communication and documentation skills
• Strong organizational skills and ability to manage multiple projects
• Willingness to travel (~30%) to supplier and CMO sites • ISO 13485 Lead Auditor certification
• Experience with IVDR compliance
• Familiarity with supplier questionnaires and quality management system evaluations
• Experience supporting FDA and Notified Body audits
• Background in managing supplier change notifications and deviations
• Prior involvement in scaling supplier tiers for new product development

Required Skill Profession

Other General


  • Job Details

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Unlock Your Sr QA Potential: Insight & Career Growth Guide


Real-time Sr QA Jobs Trends (Graphical Representation)

Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph here. Uncover the dynamic job market trends for Sr QA in South San Francisco, United States, highlighting market share and opportunities for professionals in Sr QA roles.

53912 Jobs in United States
53912
1721 Jobs in South San Francisco
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Download Sr Qa Jobs Trends in South San Francisco and United States

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The Work Culture

An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Insight Global adheres to the cultural norms as outlined by Expertini.

The fundamental ethical values are:

1. Independence

2. Loyalty

3. Impartiapty

4. Integrity

5. Accountabipty

6. Respect for human rights

7. Obeying United States laws and regulations

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The average salary range for a varies, but the pay scale is rated "Standard" in South San Francisco. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

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Insight Global interview tips for Sr QA Specialist   Supplier QA

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