Senior Supplier Quality Engineer
$100,263–$135,355 year
Hybrid · Westborough, Massachusetts, United States or Sao Paulo, São Paulo, Federative Republic of Brazil
Job Summary
Senior Supplier Quality Engineer responsible for supplier management activities across the Latin American region, including supplier qualifications, audits, Quality Assurance Agreement negotiations, and supplier risk improvement. Leads supplier quality initiatives, performs audits and surveys, assesses supplier capabilities and project risks, makes acceptance decisions, and interfaces with suppliers on systemic quality matters. Supports facility audits by regulatory bodies (FDA, ISO/MDSAP/ISP/ANVISA/COFEPRIS) and travels up to 40% internationally. Requires BA/BS in Life Science/Engineering/Physical Science with an advanced technical degree, 5+ years of related experience, FDA/medical device exposure, fluency in English and Portuguese and/or Spanish, ISO 9001 & ISO 13485 expertise, strong quality tools knowledge, MS Office proficiency, basic project management, and willingness to travel.
Required Qualifications
- BA/BS degree or equivalent in Life Science, Engineering, or Physical Science with an advanced technical degree
- Minimum of 5 years in a related field
- FDA & Medical Device experience
- Fluent in English and either Portuguese and/or Spanish
- Very good knowledge of Quality tools and methods
- Comfortable with Microsoft Office (Word, Excel, Outlook, PowerPoint) and operating a variety of websites
- Expert level knowledge of ISO 9001 & ISO 13485
- Basic project management skills
- Ability to travel up to 40% of time domestically and internationally
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