Quality Assurance Associate

About Us

Medical Developments International (MDI) is one of Australia's leading specialised pharmaceutical / medical device companies with an industry-leading range of products in areas of pain and respiratory. Most notably, our lead pain relief product is widely known here in Australia and is sold throughout the world.

At MDI, everything we do is guided by our core values: Safety First, Customer Focused, One Team, Performance Driven, and Accountability. These principles shape how we work together, serve our customers, and achieve outstanding results.

We are driven to continuously innovate and create meaningful value in all we do to improve patient experience and outcomes. We value the uniqueness and diversity of our employees and recognise that nurturing the diverse perspectives and strengths of our people translates into better patient care.

Our Opportunity

We are seeking a proactive and detail-oriented Quality Assurance Associate to support validation activities across both sites and assist the Senior Validation Associate in maintaining equipment, facilities, and processes in a validated state. The role will also contribute to operational quality, compliance, and quality systems, including product manufacture, testing, release, supplier management, document control, and training. This is a full-time and ongoing position.

Key Responsibilities include but are not limited to:

Validation:

• Manage designated equipment in conjunction with the Engineering department, ensuring timely approval of preventative maintenance and calibration activities
• Administer controlled changes to preventative maintenance and calibration schedules
• Identify and validate new equipment, utilities, processes, cleaning procedures, computer systems, analytical methods, and devices during their introduction to the business
• Prepare, review, and execute validation and qualification protocols for systems, equipment, processes, cleaning, analytical methods, and material supply to maintain the validated state
• Manage and ensure compliance with the Quality Risk Management process

Quality:

• Comply with all applicable GMP procedures, and promptly report any exceptions or deviations
• Report identified risks, customer feedback, product quality complaints, and adverse events relating to MDI products
• Prepare, issue, and review manufacturing batch documents for API manufacture, and primary and secondary packing operations
• Perform release of incoming goods and materials
• Review and approve First Article Images for incoming goods prior to dispatch from partners

Who are you?

You are a motivated self-starter with strong attention to detail and a passion for quality in regulated environments. You bring a systematic, process-driven approach and enjoy contributing to continuous improvement in a growing company.

Key Requirements/ Qualifications/Prior Experience:

• Tertiary qualifications in Science, Engineering, or a related discipline (postgraduate or training qualifications desirable).
• Minimum 2 years' validation experience with broad exposure to pharmaceutical or other regulated industries.
• Good understanding of GxP systems and processes (e.g., CAPA, complaints, controlled documentation, risk management).
• Familiarity with operational areas such as Quality Control, Manufacturing, Packaging, Warehousing, and Distribution.
• Strong technical background, with a process-based approach to problem solving and knowledge of Continuous Improvement methodologies.
• Excellent communication and interpersonal skills, and the ability to work both independently and as part of a team.
• High attention to detail, effective time management, and the ability to prioritise and complete tasks.
• Proficiency in Microsoft Office.

What do we offer?

At MDI, we will offer you:

• a competitive salary that reflects your skills and experience
• opportunities for professional development and growth
• a friendly and supportive team environment
• hybrid & flexible working
• on-site parking