Senior Supplier Quality Engineer

Working

Location:

Brazil, Sao Paolo;
Massachusetts, Westborough

Workplace Flexibility: Hybrid

This role is responsible for supplier management activities including but not limited to Supplier Qualifications, Audits, Quality Assurance Agreement negotiations, and Supplier Risk Improvement. This role is within supplier quality function with focus on the Latin American region.

• Determines appropriate supplier level (risk category) based on Supplier usage by Olympus.
• Qualifies new and remediate qualifications of existing suppliers.
• Develops documented risk improvement strategy for suppliers not meeting the minimum requirements.
• Carries out supplier audits, supplier surveys, and Quality Assurance Agreement notifications.
• Identifies gaps in suppliers’ capabilities / technical project risks.
• Makes decisions on acceptance or rejection of supplier input.
• Leads improvement projects at the supplier.
• Acts as primary interface to supplier regarding systemic quality matters.
• Supports facility audits by outside agencies (e.g., FDA, ISO/ MDSAP / ISP / ANVISA / COFEPRIS).
• Serves as first escalation path for supplier quality engineering part-level concerns.

• BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree required.
• Minimum of 5 years in a related field.
• FDA & Medical Device experience.
• Must be fluent in English and either Portuguese and/or Spanish.
• Very good knowledge of Quality tools and methods.
• Comfortable with Microsoft Office (Word, Excel, Outlook, and 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.

• Competitive salaries, annual bonus and 401(k) with company match
• Comprehensive medical, dental, vision coverage effective on start date
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center

• Work-life integrated culture that supports an employee centric mindset
• Offers onsite, hybrid and field work environments
• Paid volunteering and charitable donation/match programs
• Employee Resource Groups
• Dedicated Training Resources and Learning & Development Programs
• Paid Educational Assistance
• US Only
• Center Valley, PA and Westborough, MA

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Olympus is committed to the full inclusion of all qualified individuals. If reasonable accommodation is needed, please contact  Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus .

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.