Quality Assurance Engineer

Planet Innovation; City of Melbourne; On-site; AUD 68,000 - 91,000; Full time

Job summary

Planet Innovation is seeking an experienced Quality Assurance Engineer to ensure quality, compliance and successful release of medical devices. You will collaborate with the QA/RA team to maintain conformance with quality plans and internal standards in a fast-paced healthtech environment.

Based in Melbourne, you will review DHRs, release products, support document control and audits, and address non-conformances to ensure regulatory compliance and product quality.

Qualifications

• Formal qualifications in Science or Engineering related field or a minimum of 5 years QA experience.
• Understanding of quality compliance in manufacturing/business environments.
• Previous QA experience in the medical device industry.
• Experience in Manufacturing Quality Assurance.
• Knowledge of ISO 13485.
• Formal internal audit training.

Responsibilities

• Provide QA services to relevant areas such as Production.
• Review Device History Records (DHRs) for accuracy and compliance.
• Approve products for release and submit DHR records to clients.
• Investigate and address corrections to DHR and production records.
• Manage record retention for DHR records and related documents.
• Respond to client requests for QA information and support.
• Support QA activities including document control, audits, change control, and non-conformances.
• Assist in preparation of QA documents and work instructions.

Skills

Quality Assurance

Regulatory compliance

Medical device industry

Education

Science or Engineering degree

Internal audit training

Job description

• Permanent, Full time
• Onsite, Box Hill
• Circa $79,500

Planet Innovation (PI) is an award-winning medtech contract design and manufacturing company. We partner with leading global healthcare organisations and high-growth start-ups to create innovations that improve patient outcomes. Headquartered in Melbourne, with a growing presence in Irvine, California, we are experiencing strong demand for our consulting services across our client base.

We are looking for an experienced Quality Assurance Engineer to play a key role in ensuring the quality, compliance, and successful release of innovative medical devices that make a real impact on healthcare. Working within a leading healthtech design and manufacturing company, you'll collaborate with talented professionals while building your expertise in a supportive, high-achieving environment.

The Role

• The Quality Assurance Engineer is responsible for assisting the QA/RA team in maintaining conformance with business unit program quality plans including in-house quality standards and procedures.
• The Quality Assurance Engineer is responsible for ensuring that performance and quality products conform to established company and regulatory standards. They are responsible for reviewing, analysing and reporting on quality discrepancies and routine data related to the business unit.
• The Quality Assurance Engineer is responsible for releasing product to clients/customers, making sure devices/documents are confirming to standard and ensuring customer requirements are met.

The Accountabilities

• Provides Quality Assurance services to relevant business area such as Production.
• Review Device History Records (DHRs) and related records for accuracy, completeness and compliance with requirements.
• Approve products for release, submit DHR records to clients.
• Investigate and carry out actions to address corrections required to DHR and production records.
• Manage record retention activities for DHR records, electronic and hardcopy.
• Action and respond to client requests for production QA information.
• Support production QA activities including document control, audit support, training support, change control, non-conformance activities, calibration etc. to ensure manufacturing processes comply with international quality standards.
• Assist in preparation of QA documents including procedures, work instructions, forms etc.
• Action and manage QA tasks as assigned, participate in QA team tasks as required.
• Data entry into QA registers.
• Manage Pl Stan
• Other duties required commensurate with your skills and experience.

The Typical Experiences

• Formal qualifications in Science or Engineering related field or a minimum of 5 years QA experience.
• Understanding of quality compliance in a manufacturing/business environment.
• Previous quality assurance experience in the medical device industry
• Experience in Manufacturing Quality Assurance.
• Knowledge in ISO 13485.
• Formal internal audit training.

Salary

Circa $79,500 AUD (yearly)