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 is a 12-month maternity leave contract role that 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.