Senior Supplier Quality Engineer

Working Location: Minnesota, Brooklyn Park; Nationwide

Workplace Flexibility: Hybrid

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​ ​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus: https://www.olympusamerica.com/careers .

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 and SCN handling.

Job Duties

Develops quality assurance strategy for sourced products including suppliers and incoming inspection in cooperation with Manufacturing Quality Assurance.

Acts as a supplier quality engineering representative in new product development projects.

Performs Advanced Product Quality Planning (APQP) by applying the appropriate methods including early supplier involvement in development projects and assures that required process validations are sufficiently implemented through the External Product Qualification process.

Coordinates and ensures the external component qualification/FAI process is effective.

Identifies gaps in suppliers' capabilities / technical project risks.

Accountable for and manages Supplier Change Notification (SCN) process for sourced materials by closely and proactively working with Procurement and other cross-functional areas as necessary for timely assessment, documentation and disposition of supplier requested changes.

Accountable for incoming inspection planning for sourced materials, and makes decisions on acceptance or rejection in collaboration with receiving site.

Guides inspectors regarding incoming inspections (e.g. training, standards, etc.).

Supports site-level Material Review Boards for timely disposition of non-conforming material by owning or supporting NC Records.

Accountable for Supplier Corrective Action Request (SCAR) as part of the NC management process by working with supplier for timely resolution of identified non-conformity and prevention of potential non-conformity through verification of effectiveness.

Leads improvement projects at the supplier.

Acts as primary interface to supplier regarding product-related quality matters.

Analyzes product related supplier quality issues.

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:

Should have experience on fiber optic laser system manufacturing preferably in medical device or related Industry.

Hands on experience on system-level manufacturing processes, production equivalence verification & validation and understanding of traceability of production back to requirements in the DHF.

Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree.

Knowledge of and minimum 5 years’ experience in supplier quality engineering.

Very good knowledge of Quality tools and methods.

ISO 9001 / 13485/ FDA / Medical technology background.

Qualification in specific product group.

Basic project management skills.

Advanced English.

20% travel should be expected.

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 $98,056.00 - $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.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

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 .

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

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)