49d ago

Senior QA Specialist

Complete Financial Solutions

Similar jobs pay $100k ~ $100k
"potential for bonus"
Permanent Full time Standard business hours
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Full job description

A global leader in diagnostic technology, our client is a specialist in providing a comprehensive product range for pathology laboratories and clinicians worldwide. Their Melbourne operations boasts a strong team of design, development, and manufacturing professionals, and their talented and committed people are the reason why our client is a trusted partner to the healthcare industry.

An opportunity for an experienced QA professional with medical device experience has arisen. This role requires the Incumbent to have an in-depth understanding of design quality, along with having confident knowledge in multiple areas of medical device QA. Individuals with strong experience in IVD devices highly regarded.

Duties of the role include (but are not strictly limited to):

  • Assist with maintaining QMS, ensuring that all requirements are being met and adhered to
  • CFR 820, ISO 13485 and EU IVDR
  • Pre-market quality assurance - Design assurance and R&D QA
  • Reviewing documents for the DHF
  • Internal audits of design control projects and external audits
  • Representative for design control and risk management for NPD projects and device change initiatives
  • Carrying out CAPAs, validation activities, dealing with customer complaints and investigations, batch release, general document control

The Successful Candidate will possess:

  • Tertiary qualification in Science or related
  • At least 5 years QA experience within medical device manufacturing
  • Proven experience in design control and risk mitigation for NPD and product development lifecycle
  • Strong team player - Ability to work with all levels of an organisation and cross-functionally across departments
  • Excellent interpersonal skills - Great communication ability
  • Strong organizational skills, ability to work independently, great attention to detail

If the above sounds like you, then we want to hear from you.

Please apply with your covering letter and resume in Word format.

Questions can be directed to Aya Inazato at Fuse Recruitment on 0423 505 950.

At Fuse, we specialise in recruitment for the manufacturing industry and actively source a variety of roles for a broad range of manufacturers. If you are looking for a new opportunity, I'd love to hear from you!

If you know someone looking for a job, refer them to us and we'll give you $500* if we find them a new role!




Perks & benefits
Annual bonus
Pay comparison
Market average based on all QA Specialist jobs in Melbourne VIC
Estimated range
Market average
Market average
Actual pay is not disclosed by the employer

Job details
Date posted
6 May 2022
Science, Technology & Environment
Quality Assurance & Control
$100k ~ $100k
Contract type
Work type
Full time
Job mode
Standard business hours
Career level
Experienced non-manager
Health care equipment & supplies
Work Authorisation
Australian citizen / Permanent resident

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