Olympus Corporation of the Americas

Senior Supplier Quality Engineer

Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • BA/BS in Life Science, Engineering, or Physical Science; advanced technical degree preferred.
  • 5+ years of experience in supplier management or quality assurance in a medical device context.
  • Proficient in FDA regulations and medical device compliance.
  • Fluency in English and Portuguese and/or Spanish required.
  • Strong understanding of quality tools and methodologies, particularly ISO 9001 and ISO 13485.
  • Familiar with Microsoft Office Suite and adept at using various online platforms.
  • Basic project management skills and ability to travel up to 40% domestically and internationally.

Responsibilities

  • Determines risk categories for suppliers based on their usage.
  • Qualifies new suppliers and updates existing supplier qualifications.
  • Develops risk improvement strategies for non-compliant suppliers.
  • Conducts audits and surveys of suppliers, including notifying them of Quality Assurance Agreements.
  • Identifies technical risks and capability gaps within suppliers.
  • Decides on the approval or rejection of supplier materials.
  • Leads quality improvement projects at suppliers and serves as their primary contact for quality issues.
  • Supports external facility audits for agencies like the FDA and ANVISA.

Benefits

  • Competitive salaries and annual bonus opportunities.
  • Comprehensive medical, dental, and vision coverage from start date.
  • Access to a 24/7 Employee Assistance Program.
  • Free and on-demand wellbeing programs.
  • Generous paid vacation and sick leave policy.
  • Paid parental leave and adoption assistance.
  • 12 paid holidays throughout the year.
  • On-site childcare, café, and fitness center at select locations.
Full Job Description
Working Location: Brazil, Sao Paolo; Massachusetts, Westborough

Workplace Flexibility: Hybrid

Job Description

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.

Job Duties

  • 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 (i.e., FDA, ISO/ MDSAP / ISP / ANVISA / COFEPRIS).
  • Serves as first escalation path for supplier quality engineering part-level concerns.


Job Requirements

Required:
  • 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.

Why join Olympus?

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

Equitable Offerings you can count on:
  • 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**


Connected Culture you can embrace:
  • 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

Are you ready to be a part of our team?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position in this location is $100,263.00 - $135,355.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

About Olympus Corporation of the Americas

Olympus Corporation of the Americas is a subsidiary of Olympus Corporation, a Japanese manufacturer of optics and reprography products. The company is a leading manufacturer of medical and surgical products, including endoscopes, laparoscopes, and video imaging systems. Olympus Corporation of the Americas was founded in 1968 and is headquartered in Center Valley, Pennsylvania. The company operates in the Americas region, including North and South America.
Learn more about Olympus Corporation of the Americas
Size
31,557 employees
Industry
Founded
1919
NASDAQ

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