Quality Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

About the Role:

The Quality Engineer will be part of a cohesive team responsible for ensuring the quality of products and processes across all product lines and supporting compliance with the site’s Quality Management System.

This role acts as the technical quality anchor for the site, focusing on product and process quality, supporting new product introduction (NPI), process validation, and lifecycle quality performance. The Quality Engineer will work closely with Engineering, Operations, and R&D to ensure robust process control, effective problem solving, and continuous improvement.

What You'll Do:

• Support deployment and continuous improvement of the site Quality Management System (QMS), 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.

• Provide technical input on customer quality requirements and specifications during project execution and, where required, support tender discussions.

• Support supplier quality activities by providing technical input to supplier-related issues and improvement initiatives led by the Quality Specialist.

• Support change control, deviation management, validation activities, and in-process controls to ensure product and process compliance.

• Contribute to continuous improvement of quality processes, systems, and procedures, including requirement management, design transfer, and defect management.

• Support achievement of key quality KPIs including CAPA effectiveness, First Pass Yield (FPY), and product quality performance metrics.

• Collaborate with cross-functional teams (Engineering, Operations, R&D, Field Service) to ensure robust process control and continuous improvement.

• Remain current with relevant industry standards, regulatory requirements, and best practices.

• Support global quality initiatives and implementation of best practices at the site level.

• Other related tasks as required by management.

Education

• Bachelor’s degree in Mechatronics, Electrical, Electronics Engineering, or related discipline, or equivalent industry experience.

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.

• 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.

Knowledge, Skills, Abilities

• 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).

Other Important Information 

• 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. Where applicable, this will be managed in line with company policy.

Benefits

Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.

• Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.

• Flexibility: Balance your work and personal life with flexible arrangements.

• Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.

• Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.

• Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 125,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.