15 Aug
|
Thermo Fisher Scientific
|
Adelaide
15 Aug
Thermo Fisher Scientific
Adelaide
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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.
The role will apply structured problem-solving methodologies to investigate and resolve product and process quality issues, including warranty, Out of Box Failures (OOBF), and manufacturing non-conformances. The Quality Engineer will also provide technical input to CAPA investigations, customer requirements, and supplier-related issues where required.
In addition, the role will support the development and improvement of quality systems, processes, and documentation, ensuring alignment with regulatory and quality standards. The Quality Engineer will collaborate with cross-functional teams to support design, development, and design transfer activities, ensuring quality requirements are effectively implemented.
The successful candidate will demonstrate strong technical acumen, attention to detail, and the ability to make sound quality decisions, while effectively communicating across functions and contributing to a culture of quality and continuous improvement.
Key Responsibilities:
- 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.
Frequent Contacts:
Internal
- Quality, Field Service, Operations, R&D;, Engineering
External
- Suppliers, Customers, Regulatory Agencies
Minimum Requirements/Qualifications:
Qualifications & Experience
- Bachelor’s degree in Mechatronics, Electrical, Electronics Engineering, or related discipline, or equivalent industry experience.
- 5+ years quality engineering experience within a manufacturing workplace.
- 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.
Skills & Attributes
- 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 Job Requirements:
- 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.
📌 Quality Engineer (Adelaide)
🏢 Thermo Fisher Scientific
📍 Adelaide