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Date Added: Sun 02/01/2022

Quality Associate

Sydney, Australia
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Company: MEXEC

Job Type: Permanent, FullTime

  • MedTech
  • Healthcare
  • New role
Our Client
Our client's vision is to improve patient outcomes by developing and delivering rapid innovations in the clinical medical devices sector. They design, manufacture, and distribute products across Australia and internationally.

The Opportunity
Following a significant investment, our client is on a rapid growth trajectory and transformation. They seek a new Quality Associate to join their expanding team.
Your key remit will be to oversee the QMS function and to maintain and lead the continuous improvement of their quality system. In addition, you will work closely with stakeholders to refine the company's processes and procedures as they expand their product and instrument portfolios.
  • Ensure that all processes for the QMS are established, implemented, and maintained, and that the QMS is suitable and effective.
  • Collaborate and communicate across the company, and externally, to ensure all relevant departments have input to the development of the QA strategies and understand their role in contributing to achieving market access through QA compliance.
The Requirements
  • 3+ years' experience in Quality Management in the healthcare sector to ISO 9001 and ISO13485.
  • Tertiary qualifications with experience in a regulated clinical medical device.
  • Proven collaboration experience across multiple internal and external departments including Clinical, R&D, Supply Chain, Manufacturing, Senior Management and external Quality Consultants.
  • Hosting ISO 13485 audits and conducting internal and supplier audits an advantage.
  • Post market activities including product recalls, complaints handling, and adverse event reporting,
  • Writing of device specifications, undertaking inbound inspections, and final product releases.
  • Working with functional experts to provide timely responses to questions from the manufacturers.
  • Experience in Lean Six Sigma an advantage.
  • Engineering qualifications an advantage.
  • Exposure to the clinical sectors of orthopaedics, neurosciences &/or spine related medical devices an advantage.
  • Natural talent to influence and build relationships across an organisation to achieve success.

The Offer
You will join a company that is innovative and undergoing rapid growth and transformation. A brand-new office, combined with new processes and ERP are being implemented. You will be integral in ensuring their continued success.

For this permanent and exciting opportunity please email your cover letter & CV to #removed# Confidential enquiries to Marilyn Jones on 1300 0 MEXEC.

mexec delivers executive recruitment solutions to the pharmaceutical, biotechnology and broader technology industries. mexec comprises of highly talented and knowledgeable industry experienced Consultants that partner with leading organisations to grow their leadership teams.

We recruit at all levels including senior management, and we are currently recruiting for a variety of opportunities in the area of Sales & Marketing, Management, Medical, Regulatory Affairs, Clinical Research, Pharmacovigilance and Operations. Contact us today.
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