Senior Supplier Quality Engineer (Onsite)

Olympus

  • Brooklyn Park, MN
  • $93,793-126,621 per year
  • Permanent
  • Full-time
  • 2 months ago
Working Location: MINNESOTA, BROOKLYN PARKWorkplace Flexibility: HybridFor more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. ​​​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.​Our five Core Values empower us to achieve Our Purpose:Patient Focus, Integrity, Innovation, Impact and Empathy..Job DescriptionThe 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 QualificationsRequired:
  • Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree.
  • Demonstrated expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the IVD industry e.g., ISO, QSR, GMP, GLP, GCP, HIPAA.
  • Knowledge of and minimum 5 years' experience in supplier quality engineering.
  • High level of quality tools and methodology skills (e.g. 8D, 5-Whys, FMEA, IQ/OQ/PQ).
  • Very good written and oral communication and organizational, project management skills.
  • Technical knowledge about category supported.
  • Very good knowledge of Quality tools and methods.
  • ISO 9001 / 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 matchComprehensive medical, dental, vision coverage effective on start date24/7 Employee Assistance ProgramFree live and on-demand Wellbeing ProgramsGenerous Paid Vacation and Sick TimePaid Parental Leave and Adoption Assistance*12 Paid HolidaysOn-Site Child Daycare, Café, Fitness Center**Connected Culture you can embrace:Work-life integrated culture that supports an employee centric mindsetOffers onsite, hybrid and field work environmentsPaid volunteering and charitable donation/match programsEmployee Resource GroupsDedicated Training Resources and Learning & Development ProgramsPaid Educational Assistance*US Only**Center Valley, PA and Westborough, MAAre you ready to be a part of our team?.The anticipated base pay range for this full-time position working at this location is $93,793.00 - $126,621.00 / 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 .You Belong at OlympusWe value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.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) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA)

Olympus