In-Demand Quality assurance medical device Jobs in Melbourne Vic

Quality Assurance Engineer
PSC Biotech —Melbourne VIC
- Contract
- Engineering
- Education
- Bachelor's degree
2d
Senior Manager - National Quality Assurance, Healthcare
Toll Group —Melbourne VIC
- Full-time
- Leadership
Field Safety and Quality Specialist I Melbourne Metro West
NBN Co —Melbourne VIC
- Full-time
- Construction experience
- Communication skills
- Parental leave
- Employee assistance program
20h
Placement Coordinator, Clinical Psychology
RMIT University —Melbourne VIC
- $121,213 - $136,507 a year
- Part-time
- Administrative experience
- Analysis skills
- University
2d
Senior Specialist, QARC
Leica Biosystems —Mount Waverley VIC
- Full-time
- Engineering
- Bachelor's degree
- In-person
- Annual leave
1d
DSO Customer Success & Education Coordinator
Straumann —Melbourne VIC
- $75,000 - $90,000 a year
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- CRM software
Senior Field Technician I Wagga Wagga
NBN Co —Melbourne VIC
- Full-time
- Customer service
- Communication skills
- Parental leave
- Gym membership
Assembler
LivaNova —Melbourne VIC
- Full-time
- Research
- Assembly
- Communication skills
Senior Field Technician I Horsham
NBN Co —Melbourne VIC
- Full-time
- Customer service
- Communication skills
- Parental leave
- Gym membership
Cyber Governance, Risk and Compliance Lead
Monash Health —Clayton VIC
- Full-time
- Patient monitoring
- No degree
9d
Associate Professor, Biomedical Science
RMIT University —Melbourne VIC
- $176,883 - $194,867 a year
- Full-time
- Doctoral degree
- Master's degree
- University

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Quality Assurance Engineer

PSC Biotech -
Melbourne VIC

Apply Now

Job Details

Contract | Fixed term
2 days ago

Qualifications

Engineering
Quality assurance
Education
Bachelor's degree
Manufacturing
FDA regulations

Full Job Description

Job Information

Date Opened

07/08/2026

Job Type

Consultant

Industry

Pharma

City

Melbourne

State/Province

Victoria

Country

Australia

Job Description

POSITION SUMMARY:

We are looking for a Quality Assurance Engineer to join our team on a 12-month contract. The Quality Assurance Engineer is responsible for providing Quality Assurance oversight and support for commissioning, qualification, validation, technology transfer, process lifecycle management, capital projects, vendor qualification, and operational quality activities. This role is accountable for maintaining quality and compliance throughout the project lifecycle while supporting successful project execution and commercial operations. The incumbent is also responsible and accountable for the execution of the PSC mission, “to maintain the integrity and professionalism of our products and services while enabling steady growth and development”.

DUTIES AND RESPONSIBILITIES:

Provide Quality Assurance oversight for engineering, validation, manufacturing, and capital project activities.
Review and approve GMP-related documents, including validation protocols, qualification documents, risk assessments, technical transfer documentation, and quality system records.
Support commissioning, qualification, validation, technology transfer, and process lifecycle activities to ensure compliance with regulatory and company requirements.
Facilitate and support quality systems including deviations, investigations, change controls, CAPA, and risk management activities.
Ensure compliance with cGMP, GxP, site procedures, and applicable global regulatory requirements.
Provide quality guidance and risk-based decision-making to project teams and operational stakeholders.
Collaborate with Engineering, Manufacturing, Validation, Quality Control, Supply Chain, and Regulatory teams to achieve project and business objectives.
Participate in audits, inspections, and continuous improvement initiatives to maintain and enhance compliance and quality performance.
Support vendor qualification and supplier quality activities as required.
Additional duties and responsibilities may be assigned from time to time.

DEMONSTRATED COMPETENCIES:

Quality & Compliance Excellence – Strong understanding of cGMP, GxP principles, quality systems, validation lifecycle requirements, and global regulatory expectations.
Relationship Building – Works with and across formal and informal professional and social networks to build long-term partnerships and connections in the life science industry.
Problem solving – Identifies, researches, and demonstrates logical reasoning to communicate critical information.
Rational Persuasion –, Active listening, Presents key factors influencing factors, and strategic goals to assist stakeholders in identifying solutions.
Interpersonal Awareness – Ability to be aware of how actions, ideas, and communication can/does affect people and their outcomes.
Agility – Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines.

Requirements

REQUIRED EDUCATION AND WORK EXPERIENCE:

Bachelor’s Degree in Engineering or Life Science.
Minimum 4 years of experience in Quality Assurance, Validation, , Manufacturing Quality, or Project Quality within the pharmaceutical, biotechnology, medical device, or other regulated industries.
Demonstrated experience reviewing and approving GMP documentation including risk assessments, validation protocols, qualification documents, change controls, deviations, and CAPAs.
Experience supporting technology transfer, process validation, qualification, engineering, manufacturing, or capital projects.
Working knowledge of cGMP, GxP, FDA, EMA, TGA, PIC/S, and international regulatory requirements.
Strong technical writing and document review skills.
Ability to build and maintain relationships with stakeholders across multiple functions and organizational levels.

Apply Now

Refine Your Search

quality assurance medical device jobs in melbourne vic

Quality Assurance Engineer

Senior Manager - National Quality Assurance, Healthcare

Field Safety and Quality Specialist I Melbourne Metro West

Placement Coordinator, Clinical Psychology

Senior Specialist, QARC

DSO Customer Success & Education Coordinator

Senior Field Technician I Wagga Wagga

Assembler

Senior Field Technician I Horsham

Cyber Governance, Risk and Compliance Lead

Associate Professor, Biomedical Science

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