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Thermo Fisher ScientificPosted 2 weeks ago

Quality Engineer

On-siteAdelaide, South Australia, Australia

Full TimeLarge

Job Summary

Support deployment and continuous improvement of the site Quality Management System (QMS) while ensuring compliance with internal and regulatory requirements. Lead product and process quality activities across the lifecycle, including New Product Introduction (NPI), process validation, and First Article Inspection (FAI). Perform and maintain product and process risk analysis (FMEA, DFMEA, PFMEA), and provide technical input to investigations of non-conformances, audit findings, CAPA, complaints, and SCARs. Apply structured problem-solving methodologies to investigate and resolve product and process quality issues, including warranty claims and Out of Box Failures (OOBF). Develop and maintain quality documentation including control plans, Inspection and Test Plans (ITPs), Certificates of Compliance, and manufacturing data reports. Collaborate with cross-functional teams (Engineering, Operations, R&D) to ensure robust process control and continuous improvement. Support global quality initiatives and implementation of best practices at the site level.

Required Qualifications

  • Bachelor's degree in Mechatronics, Electrical, Electronics Engineering, or related discipline, or equivalent industry experience
  • 5+ years quality engineering experience within a manufacturing environment
  • Strong experience working in cross-functional teams (Engineering, Operations, R&D) to resolve product and process quality issues
  • Experience in structured problem-solving methodologies (e.g. 8D, Root Cause Analysis, Lean tools)
  • Working knowledge of ISO 9001 quality management systems
  • Strong interpersonal and communication skills, with the ability to engage and influence stakeholders across all levels of the organisation
  • Demonstrated ability to work effectively in cross-functional teams (Engineering, Operations, R&D) and drive alignment on quality decisions
  • Proven capability in structured problem-solving, with the ability to lead root cause analysis and drive effective, sustainable solutions
  • Ability to manage multiple priorities in a fast-paced manufacturing environment while maintaining focus on quality outcomes
  • Strong sense of ownership and accountability, with a proactive approach to identifying and resolving quality issues
  • High attention to detail with a disciplined and methodical approach to work
  • Ability to think systematically and understand end-to-end product and process flows
  • Strong organizational, planning, and follow-up skills to ensure timely closure of actions and commitments
  • Self-motivated, adaptable, and able to work both independently and collaboratively within a team environment
  • Proficient in Microsoft Office tools (Word, Excel, PowerPoint)
  • Comply with all EHS policies and procedures and actively contribute to maintaining a safe and healthy workplace
  • Adhere to Chain of Responsibility (CoR) obligations under the Australian Heavy Vehicle National Law, where applicable
  • The role may require participation in on-call support activities from time to time

Desired Qualifications

  • Basic understanding of applicable regulatory and compliance requirements for electromechanical products (e.g. CE, ROHS) would be beneficial
  • Knowledge of manufacturing processes such as metal fabrication, assembly, or coating processes would be beneficial
  • Lead Auditor certification would be beneficial

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