- Investigate and report on internal batch failures and customer complaints.
- Coordinate and support Production and Quality Control to investigate problems, analyse trends, identify root causes, and implement corrective actions for processes and products.
- Be an effective leader in promoting quality-focused decisions using sound problem-solving methods to identify, prioritise, and resolve quality issues, thus reducing technical risk and improving efficiency.
- Report results and investigation findings in an accurate, clear, and concise manner.
- Maintain and manage the Incident & CAPA systems to drive completion within metrics targets.
- Provide QA support and approvals to Operations for validation protocols, validation reports, change control, SOPs, and in-process controls.
- Complete process/product validation testing and prepare reports as needed.
- Mentor and assist production team to maintain ISO13485/Quality system compliance including developing SOPs and standard work instructions for consistent process control.
- Facilitate risk management activities across all quality system processes in line with medical device standard requirements.
- Perform QA review and approval of external calibration and maintenance reports in addition to assisting site maintenance team to maintain compliance with ISO13485.
- Author and deliver QMS and process training when required.
- Engage in completing the site Internal audit program and assisting with third party/customer audits
Frequent Contacts
- Internal: Site Quality Manager & QA/QC Team, Production Engineer, Operations Leaders, Production Operators, Maintenance staff.
- Division: MBD Senior Validation Manager (UK).
- External: Suppliers and customers as required.
Qualifications & Experience
- Tertiary qualification required in an Engineering or Science-related field.
- Minimum of 3-5 years of quality assurance/quality systems experience.
- Proficiency in Excel and Word.
- Lean Six Sigma Green Belt or similar process improvement qualification.
- Experience in a medical device or pharmaceutical manufacturing environment desirable.
- Internal auditing experience favourable.
Skills & Abilities
- Able to use own initiative, prioritise multiple tasks, and achieve goals within agreed timeframes.
- Team-focused with proven ability to coordinate activities and influence outcomes across teams and functions where no formal authority exists.
- Effective written and oral communication skills.
- Solid problem analysis and decision-making skills.
- Expertise in quality-related tools like structured problem solving, FMEA, SPC, DOE, and Lean-Six Sigma/PPI.
- Understanding of Medical device, GMP, or ISO 13485 principles.
Other Job Requirements
- Projects or other work as determined by the Quality Manager or site leadership team.
- Support and actively participate in the company PPI (Continuous improvement) program
- Additional work outside regular hours may occasionally be necessary
Benefits
Join our team and take advantage of these great benefits!
Required Skill Profession
Engineers
📌 Quality Engineer
🏢 Thermo Fisher Scientific
📍 Adelaide