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QA Specialist

An exciting opportunity has arisen for an experienced Quality Specialist to join a dynamic team. The business is undergoing significant worldwide growth and has an immediate need for a new member to join their Quality team in a start up role based in Melbourne.

Client Details

Our client is a leading provider of infection prevention products and services in the health care market, with a number of specialist areas. For decades they have been dominating the medical device market with consistent release of new and innovative product to the market. With a large amount of recent growth, they have acquired a number of businesses and now have exciting plans in place to move into the Melbourne market.


An opportunity has arisen for an experienced Quality Specialist to join their start up Melbourne operation. The business is currently undergoing some growth and changes both here and in the overseas facility, and as a result has an immediate need for a new member to manage the Quality team. Reporting directly to the Vice President of Quality, the QA Specialist will be responsible for managing all the activities across the Quality department and liaising with clients. Duties will include and not be limited to:

  • Maintain the Quality management System and corporate compliance to ISO 13485 and ISO9001

  • Ensure conformance of product within the group of companies an hold responsibility for product quality and release of sale functions

  • Maintain an audit ready status across the group and manage all regulatory audits

  • Evaluate opportunities for improvement to the operation of the Quality department

  • Preparation and maintenance of all documentation related to product Quality and conformance

  • Update of company training programs and records

  • Manage and maintain company systems "Change Control", NCR and "Customer Complaint" systems

  • Ensure compliance with OH&S requirements and report on company risk management systems

Other duties such as Post Market review, Supplier Management, Regulatory Support, Agency Interaction (FDA and TGA)


The successful applicant should possess the following skills.

  • BA or B.Sc degree required, Diploma holder in Life Sciences or Bio-engineering

  • 2-3 years of Quality Assurance experience in Medical Device environment with particular exposure to managing a customer complaint handling system

  • Experience with compliance to FDA and/or ISO regulations

  • Medical device knowledge is preferred.

  • Must have a vast knowledge of HACCP, GMP and experience with leading audits

  • Sound leadership and good communication skills

  • Dealing with customer complaints and experience with management of suppliers

  • Proficiency with MS Office programs and sound computer skills.

Job Offer

An attractive salary package will be on offer to the successful candidate along with the opportunity to take leadership and ownership in moulding the Quality department. There are also a number of worldwide career opportunities within the company global footprint.

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Mark McBreen on +61 3 8640 3136

Date Posted
Quality Assurance & Safety
Melbourne, VIC 3000
Job Type
Full Time, Permanent
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