Our client is a busy biotechnology manufacturer specialising in the field of custom diagnostics. Their state-of-the-art facility is GMP and ISO 13485 regulated, whilst also having the ability to customise their manufacturing processes to meet additional regulatory requirements.
A fantastic opportunity for an experience Quality Manager to join the team has arisen. The QA Manager will be the lead in the design, development, implementation, maintenance, and improvement of the site's quality management system, along with championing a culture of quality across the business.
The QA Manager role will involve:
- Management of the site's Quality Management System, accreditation, and related activities
- Ensure compliance with the relevant quality management system and licencing and/or accreditation body requirements (ISO 9001 and ISO 13485, TGA etc.)
- Manage, lead and coordinate all quality related activities in an effective, efficient and compliant manner by delegating tasks among team members.
- Coordinate and manage quality related customer requirements, ensuring timely customer engagement and resolution
- Quality lead in the on-boarding of new customer and new customer products, advising on best quality practices and risk mitigation during the initial discussions, pilot and commercialisation phase
- Ensure supplier and third-party qualification and auditing programs are in place, effective and maintained, and complete vendor audits
- Coordinate and manage internal audit programs. Ensure timely resolution of findings and that an efficient audit issue management and tracking system is in place
- Coordinate and lead external audits
- Manage, coordinate and report on product and process deviations, non- conforming products, customer complaints and audit observations
- Manage, coordinate and report on the site's CAPA programs, change control program, and QC compliance programs and systems
- Design, develop, implement, and manage the validation system, validation programs and validation commitments. Ensure validations are completed in a timely manner
The Successful Candidate will possess:
- Bachelor of Science or related
- Ideally a minimum of 5 years working in a similar role within a medical device manufacturing environment
- Experience working within a GMP, ISO 9001, ISO 13485 and TGA regulated environment
- Experience with validation activities
- Experience working in a cleanroom
- Excellent communication skills - Both written and verbal
- Ability to work effectively in a busy manufacturing environment
Questions can be directed to Aya Inazato at Fuse Recruitment on 0423 505 950.
Please apply with your CV and covering letter in Word format, not PDF.
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!