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Senior Supplier Quality Engineer

Olympus Medical Systems

Olympus Medical Systems

Quality Assurance
Westborough, MA, USA
Posted on Thursday, March 14, 2024

Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Senior Supplier Quality Engineer is responsible for the product-related supplier quality within a defined material segment and / or site including part approval, SCAR handling, development project support, sustaining engineering support including non-conformance handling and incoming inspection planning.

Job Duties

  • Develops quality assurance strategy for sourced products including suppliers and incoming inspection in cooperation with Manufacturing Quality Assurance
  • Acts as supplier quality engineering representative in new product development projects
  • Performs Advanced Product Quality Planning (APQP) by applying the appropriate methods including early supplier involvement into development projects and assures that required process validations are sufficiently implemented
  • Coordinates and ensures the external component qualification/FAI process is effective
  • Identifies gaps in suppliers' capabilities / technical project risks
  • Accountable for incoming inspection planning
  • Makes decisions on acceptance or rejection of sourced materials
  • Guides inspectors regarding incoming inspections (e. g. training, standards, etc.)
  • Responsible for SCAR process as part of the NC process
  • Leads improvement projects at the supplier
  • Acts as primary interface to supplier regarding product related quality matters
  • Analyzes product related supplier quality issues
  • Is part of the material review boards
  • Supports facility audits by outside agencies (i.e., FDA, ISO/ MDSAP)
  • Supports Supplier audits as co-auditor
  • Performs local supplier management such as supplier approval, supplier auditing, QAA negotiation and supplier evaluation if delegated by SQM

Job Qualifications

Required:

  • Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree.
  • Minimum of 5-10 years in a related field.
  • Very good knowledge of Quality tools and methods
  • ISO 9001 I FDA I Medical technology background
  • Basic project management skills
  • Advanced English
  • 20% travel should be expected.

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

  • Competitive salaries, annual bonus and 401(k)* with company match
  • Comprehensive Medical, Dental, Visions coverage effective on start date
  • 24/7 Employee Assistance Program
  • Free virtual live and on-demand wellness classes
  • Work-life balance supportive culture with hybrid and remote roles
  • 12 Paid Holidays
  • Educational Assistance
  • Parental Leave and Adoption Assistance
  • Volunteering and charitable donation match programs
  • Diversity & Inclusion Programs including Colleague Affinity Networks
  • On-Site Child Daycare, Café, Fitness Center**

*US Only

**Limited locations

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.

About us:

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

Let’s realize your potential, together.

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.

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)