Quality Assurance Specialist

1 month ago

Portland, Oregon, United States RIVERPOINT MEDICAL LLC Full time
Job Title: Quality Engineer

Riverpoint Medical LLC is seeking a highly skilled Quality Engineer to join our team. As a Quality Engineer, you will play a critical role in driving proactive improvements to our quality systems and processes.

Key Responsibilities:
  • Collaborate with Operations and Engineering to ensure product quality and conformance to specifications.
  • Manage and resolve non-conformities, lead process and equipment validations, and resolve customer issues.
  • Drive continuous improvement activities in the quality system.
  • Navigate FDA QSR 21 CFR part 820, EU MDR, and ISO 13485 regulations.
  • Coordinate planning, implementation, and trending of multiple quality management systems.
  • Perform internal and supplier audits.
  • Perform risk assessment activities to identify product quality or compliance risks and lead efforts to mitigate those risks.
  • Create and update SOPs, WI, and forms as necessary.
  • Implement approved changes using quality engineering principles and fully document them in compliance with Riverpoint Medical policies and procedures.
  • Assist in investigations of quality events related to Riverpoint Medical products and appropriate reporting of such events to US and foreign regulatory authorities and notified bodies as applicable.
  • Lead supplier performance management activities in support of established quality standards.
  • Promote compliance to company procedures.
Requirements:
  • BS in engineering or related subject with 2+ years related experience in the medical device industry or MS in engineering or related subject.
  • Work experience in an ISO13485 or FDA regulated environment.
  • Familiarity with NCR and CAPA systems.
  • Product failure investigations.
  • Use of Failure Mode Effects Analysis (FMEA).
  • Excellent verbal and written communication skills.
  • Computer skills including MS Word, Excel, and PowerPoint.
  • Demonstrated technical writing skills.
What We Offer:

We offer a competitive salary, comprehensive benefits package, including medical, dental, and vision insurance, life and accidental death insurance, 401(k) with company match and immediate vesting, paid time off, and 8 company paid holidays.

Riverpoint Medical LLC is committed to a diverse and inclusive workplace. We are an equal opportunity employer and do 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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