Quality Engineer

Quality, regulatory and pharmacovigilance groups work across every site. Granitekeep Therapeutics is a global biopharmaceutical company with medicines approved in more than 60 countries.

The position:

Granitekeep Therapeutics is hiring a Quality Engineer to support production and handle customer complaints at our Sydney plant. The work is on site and cannot be done remotely.

Essential duties and responsibilities:

• Train production staff on quality requirements.
• Respond to customer complaints and write 8D reports.
• Chair MRB meetings and disposition nonconforming material.
• Validate processes through IQ, OQ and PQ.
• Own the CAPA and NCR processes for assigned product lines.
• Support customer and registrar audits.

Minimum qualifications:

• 2+ years of quality engineering experience in manufacturing.
• Proficient in Minitab or similar statistical software.
• Can read drawings and apply GD&T.
• Hands-on with root cause tools: 8D, fishbone, 5 Whys.
• Working knowledge of ISO 9001, plus AS9100, ISO 13485 or IATF 16949 depending on site.

Nice to have:

• Six Sigma Black Belt.
• APQP and PPAP for automotive.
• Lead auditor certification.

Schedule: Travel to suppliers, up to 20%

Perks and benefits:

• Superannuation on top of salary.
• Additional leave days.
• Above-award pay rates.
• Employee assistance program.

Aboriginal and Torres Strait Islander people are encouraged to apply.

Applications close when we find the right person, so get in early.

Start: Immediately.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Granitekeep Therapeutics.