Senior Leader, Quality Excellence

7 days ago

Melbourne, Victoria, Australia beBeeQuality Full time $175,000 - $225,000

About This Role

We are seeking an experienced leader to spearhead our Quality Affairs division. In this pivotal position, you will be responsible for maintaining and enhancing our Quality Management System (QMS) in alignment with ISO 13485 and FDA 21 CFR Part 820 standards.

You will ensure ongoing certification and global compliance with regulatory bodies. You will provide regular reports to senior management on the effectiveness and performance of the QMS, playing a critical role in driving quality, compliance, and continuous improvement across the organization.

Key Responsibilities

  • Lead and manage the Quality Assurance, Post Market Surveillance, and Quality Control teams.
  • Continuously review and improve the QMS to reflect all processes involved in designing, developing, manufacturing, and distributing medical devices.
  • Liaise with staff to develop strategies to mitigate risks to device safety, performance, and efficacy.
  • Maintain controlled documents in accordance with documented procedures.
  • Ensure Batch Process Records, QC release testing, raw material/product reports, and labelling protocols are reviewed and maintained in accordance with defined manufacturing and QMS standards.

About You

We require a degree holder in science, biomedical science/biotechnology or a related field, with at least five years' experience managing Quality Assurance functions in a regulated environment. You should have a deep understanding of ISO 13485 and/or GMP (21 CFR 820). Proven leadership experience, exceptional communication and interpersonal skills, strong project management capabilities, excellent analytical and problem-solving skills, and high professionalism are essential.

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