Senior Supplier Quality Assurance Engineer
$90,000–$180,000 year
On-site · Alameda, California, United States
Job Summary
Senior Supplier Quality Assurance Engineer at Abbott, located in Alameda, CA. Lead supplier quality activities to ensure compliance with ISO 13485, FDA QSR, MDR/IVDR and other global requirements; own onboarding, qualification, and requalification of suppliers; plan and conduct remote, desktop, and on-site audits; drive CAPAs and corrective actions; analyze data with dashboards and KPIs; collaborate with Procurement, R&D, Manufacturing, and Regulatory Affairs to resolve supplier quality issues; contribute to supplier selection and development; operate within a regulated environment for medical devices and related products; travel up to 10% annually.
Required Qualifications
- Bachelor’s degree in engineering, Life Sciences, Quality, or related technical field or equivalent combination of education/experience
- Minimum 5 years in Supplier Quality, Quality Engineering, Supply Chain Quality, or applicable industry experience
- Experience with ISO 13485, FDA QSR (21 CFR 820), ISO 14971, and MDR
- Demonstrated experience participating in, conducting, or leading supplier audits (remote and onsite)
- Proficiency in root cause analysis, CAPA management, risk analysis, and supplier issue resolution
- Knowledge of supplier qualification, risk management, and process validation (IQ/OQ/PQ)
- Ability to present supplier performance metrics and provide improvement recommendations to leadership
- Strong communication and cross-functional leadership skills
- Ability to travel up to 10% annually (national and international)
- Preferred: Advanced degree (MS, MBA) or professional certifications (ASQ CQA, CQE, CSQP, Six Sigma)
- Direct experience in medical device manufacturing or other highly regulated environments
Additional Requirements
- Travel up to 10% annually (national and international)
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