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Date Added: Thu 17/03/2022

Quality Manager - Medical Device - Brisbane

Brisbane, Australia
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Company: I-PHARM CONSULTING

Job Type: Permanent, FullTime

ROLE / RESPONSIBILITIES

  • Quality Management; management of SOPs, WI, etc and compliance with these specifications, organise and oversee training programs, participation in both internal and external audits
  • Qualification and Validation; creating and maintaining the Qualification/Validation Master Plan, supporting the creation of User Requirements Specifications and Design Specifications, carrying out risk analyses (FMEA), IQs, OQs and PQs
  • Quality Planning; Planning, coordinating and monitoring all quality-assurance measures, creating and maintaining inspection plans/instructions/schedules
  • Complaint Handling; Ensuring proper complaint recording, implementation and control of the root cause analysis and evaluating complaint statistics
  • Continuous improvement; identification of improvement potential on existing products and processes, planning, coordinating and monitoring improvement measures

REQUIREMENTS

  • Minimum 3 years' experience in a relevant quality role.
  • Relevant scientific or engineering degree
  • Medical device experience preferred
  • Advanced interpersonal and communication skills, strong people & business leadership skills.
  • Ability to effectively manage multiple projects and priorities.
  • Strong analytical, planning and problem-solving skills.
  • Demonstrated skills in MS-Office suite, Adobe, and SAP.
  • Able to work independently under minimal supervision.
  • Able to efficiently communicate and collaborate amongst a team, people management experience preferred.
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