Supplier Quality Engineer II

1 week ago

Portland, United States Riverpoint Medical Full time
Job DescriptionJob Description

Riverpoint Medical in Northeast Portland is hiring a Supplier Quality Engineer II. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. The Riverpoint Supplier Quality Engineer II has overall responsibility for executing overall supplier management activities including supporting receiving inspection product quality. They will improve product quality through establishment of improved processes and methods both internally and in collaboration with our supplier partners.

Duties and Responsibilities:

  • Provide supplier quality engineering support in developing test methods, equipment acquisition for new product testing, component validations/qualifications, statistical analysis of data for significance, and other documented requirements for quality objectives.
  • Ensure receiving and supplier process control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
  • Responsible for non-conformance identification and evaluation.
  • Partner with suppliers on the development and implementation of supplier corrective actions (SCAR).
  • Utilize statistical tools including process capability and measurement system analysis and tolerance interval analysis with proficiency in Minitab.
  • Responsible for ensuring supplier processes are able to meet all internal and external requirements through process validation or verification methods.
  • Drives CAPA and Nonconformance investigations and ensures that corrective measures meet acceptable standards. Works cross-functionally to achieve optimal results.
  • Utilize problem solving tools using Define, Measure, Analyze, Improve, and Control (DMAIC) methodology.
  • Navigate FDA QSR 21 CFR part 820, EU MDR, and ISO 13485 regulations
  • Coordinate planning, implementation and trending of multiple quality management systems including CAPA, SCAR, and non-conformances.
  • Performs all aspects of supplier management including audits, scorecards, quality reviews, receiving inspection non-conformances, supplier feedback
  • Leads supplier development activities and continuous improvement initiatives
  • Leads supplier change management processes
  • Leads component qualifications/FAIs to ensure supplier and component requirements perform as intended, as required.
  • Coordinates document change process and documents

Education and Qualifications

  • Bachelor Degree in Engineering or similar
  • CAPA planning and implementation
  • Use of Failure Mode Effects Analysis (FMEA)
  • Work experience in an ISO13485 or FDA regulated environment
  • Computer skills, including Word and Excel
  • Demonstrated technical writing skills
  • 3+yrs experience in supplier quality management in an FDA regulated environment is desirable, with an understanding of cGMP, QSR, ISO13485, MDSAP, and MDR

We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 8 company paid holidays. We also reward our team with bonus pay such as Referral Bonus and Annual Bonus

Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

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