Address
Form of workJob Opportunity: Quality Assurance Engineer - Medical Devices
Location: Sydney, Australia
Hybrid days and flexible working hours are available
Salary: $90,000 - 130,000 + Super
Are you passionate about ensuring the safety and efficacy of medical devices? Are you skilled in Quality assurance practices and regulatory compliance? Join our team as a Quality Assurance Engineer based in Sydney.
Requirements:
- Tertiary Qualifications in Science, Engineering, Biotechnology, Biological Sciences, or equivalent qualifications.
- Minimum 2 years’ experience in a Quality and/or Regulatory function, preferably in the Medical Devices Industry.
- Proven expertise with ISO 13485 and 21 CFR Part 820 requirements.
- Demonstrated proficiency in Design Control and crafting Medical Device Technical Documentation.
- Formal training and experience in Quality Systems audits.
- Ability to think critically, assess information, and make informed decisions promptly.
- Strong written and verbal communication skills, coupled with excellent organizational and prioritization abilities, and meticulous attention to detail.
- Collaboration with engineering teams to translate inputs into comprehensive design control documentation.
- Stay updated on regulatory changes and standards applicable to the business, facilitating collaborative responses with product development teams.
- Oversight of documentation related to design and development activities, aligned with the design and development plan and regulatory strategies.
- Champion significant quality projects across the business and contribute to enhancing quality and business processes.
- Conduct internal audits and provide support for external and supplier audits.
Nice-To-Have Requirements:
- Prior experience with regulatory submissions or technical file compilation.
- Experience with products encompassing hardware and software development.
- Familiarity with Good Manufacturing Practice (GMP).
- We are committed to fostering a collaborative and innovative environment where your contributions make a meaningful impact on healthcare outcomes. If you're ready to take on this exciting opportunity, apply now and become a part of our dynamic team dedicated to advancing medical technology for the betterment of society.
Please reach out to ****@pgrec.au for more info
