Production QA Specialist

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries?
PQE Group
has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2,000 employees across Europe, Asia, and the Americas.

Due to our constant growth, we are looking for a
Production QA Specialist
to support our projects in Melbourne,
Australia.

You will be responsible for
:

• Ensuring robust documentation, management, and execution of Production Quality Assurance processes within Manufacturing.
• Preparing high-quality Non-Conformance Reports (NCRs) and coordinating with Production, QA, Engineering, and other stakeholders to ensure timely progression through the QMS workflow.
• Maintaining clear and accurate linkages between NCRs and related quality records, including CAPAs, SCARs, CCRs, and DCRs.
• Leading root cause investigations using structured methodologies such as 5 Whys, Fishbone, and risk assessment techniques.
• Developing investigation plans, collecting and analyzing data, conducting interviews, and documenting clear, justified investigation outcomes.
• Facilitating cross-functional investigation teams involving Production, QA, Validation, Engineering, and R&D, and presenting findings at Material Review or CAPA Review Boards as required.
• Managing CAPAs end-to-end across all six CAPA phases, ensuring high-quality documentation, timely execution, and effective closure.
• Coordinating cross-functional inputs to CAPAs, tracking actions, and driving accountability through regular reviews and meetings.
• Supporting QMS oversight by maintaining required quality records and contributing to continuous improvement of procedures, templates, MBR content, and investigation tools.
• Providing training, guidance, and coaching to Production staff on NCR escalation, investigation standards, documentation quality, and ETQ Reliance workflows.
• Complying with workplace health and safety policies and proactively reporting hazards, incidents, and near misses.

About You:

• You have at least
  6 years of experience
  in QA, Production QA support, or regulated medical device manufacturing environments.
• You bring a strong understanding of NCR, CAPA, SCAR, DCR, and CCR processes within a regulated QMS.
• You are experienced in leading investigations and writing clear, structured NCR and CAPA documentation.
• You are confident using root cause analysis tools such as 5 Whys, Fishbone, and FMEA.
• You can interpret Manufacturing Batch Records, SOPs, Work Instructions, and equipment qualification documentation with ease.
• You are highly detail-oriented, with strong written communication skills and a disciplined approach to task tracking and follow-up.
• You are comfortable leading cross-functional teams, influencing stakeholders, and driving issues to resolution.
• You are analytical, solutions-focused, and motivated by continuous improvement and quality excellence.

Location:
Full on-site, Melbourne, Victoria

Contract Type:
Temporary, 6 months (renewable based on project requirements)

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome following the Hiring Manager interview, the recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group offers the opportunity to work on international projects, continuously improve your skills, and collaborate with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career,
PQE Group is the perfect place for you
.

Apply now
and take the first step towards an amazing future with us.