Medical Device Compliance Specialist

5 days ago

Perth, Western Australia beBeeQuality Full time US$60,000 - US$70,000

Our team is dedicated to delivering exceptional outcomes for patients. We are developing a first-in-class biomimetic TAVR valve and are seeking a Quality Assurance Associate to join our Malaga team.

As a Quality Assurance Associate, you will participate in ongoing quality compliance activities to ensure that our medical device products are safe for patients. Your primary responsibilities will include:

  • Document control: maintaining documents within Grand Avenue, releasing documents for review, and removing documents from use
  • Review of Batch Records to ensure manufacturing procedures were followed and there are no issues with product
  • Record Review: reviewing records generated for completeness and adherence to required processes and procedures
  • Coordination of supplier evaluations
  • Record Archive: ensuring all records are stored and archived in accordance with procedures and regulations
  • Deviations & Nonconformances: reviewing deviations (nonconformances) raised, reviewing and closing out completed investigations, and raising CAPAs where indicated
  • Preparation and conduct of internal audits as required
  • Participation in projects for aligning systems and processes with regulatory requirements
  • Continuous improvement projects
  • Review, revision, and creation of procedures and documents, as required

In consultation with the Director of Quality, you will prepare reports according to areas of responsibility for weekly departmental and organizational meetings.

Additional responsibilities will include:

  • Printing batch records and labels for product manufacture and final products
  • Assisting in material release when needed
  • Assisting in AQL of final product when required

Key qualifications for this role include:

  • Tertiary qualification in a science field or extensive understanding of ISO 13485 requirements and administration
  • Prior experience working within a quality management system
  • Proficiency in Microsoft computer software
  • Sound communication and interpersonal skills
  • Strong organizational skills and able to prioritize effectively
  • Attention to detail
  • Administrative competencies

This is an 8 hour shift position based in Malaga, WA. Ability to commute to Malaga, WA is required. Preference is given to candidates who are able to relocate to Malaga, WA prior to starting work.

Work location: In person.

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