Costa Rica Quality Assurance Specialist

hace 1 día

Alajuela, Alajuela, Costa Rica Riverpoint Medical A tiempo completo

Riverpoint Medical, a leading manufacturer of premium medical devices, is seeking a dedicated Quality Assurance Specialist to join our team in Costa Rica.

About the Role:

The Quality Assurance Specialist will be responsible for driving proactive improvements to quality systems and processes, ensuring product quality and conformance to specifications, managing and resolving non-conformities, leading process and equipment validations, resolving customer issues, and driving continuous improvement activities in the quality system.

Duties and Responsibilities:

  • Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
  • 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.
  • 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 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:

  • Work experience in an ISO 13485 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.

About Riverpoint Medical:

Riverpoint Medical 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.

Salary: $80,000 - $110,000 per annum, depending on experience.

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