| An exciting opportunity for entry into a medical device company working with a cross-functional team on cardiac products in the area of diagnostic cardiac pacing and arrhythmia treatment. Micropace is a long-established, successful company located in Homebush West, NSW, with global reach and leadership in cardiac stimulation, partnering with companies like GE Healthcare and Boston Scientific. |
Position: Graduate Quality Assurance and Systems Engineer
Micropace Pty Ltd. offers an opportunity for a Graduate QA and Systems Engineer with approximately 1 year of experience in a biomedical or highly regulated industry.
Located in Homebush West, NSW, Micropace is a long-established company and is a leader in cardiac stimulation with a global reach. The company is number one in the US market, partnering with major international companies.
You will report to the QA Manager and will play a pivotal role in ensuring our operations comply with the company’s Quality management system, which has a high standard of compliance with ISO13485, ISO14971, EU MDR, FDA and TGA.
About you
You’re a problem-solver who is curious and pays close attention to details. You appreciate working in teams and do well in intricate and multi-layered settings. You’re analytical, proactive, and dedicated to lifelong learning.
Key Responsibilities
- Implement and manage the company’s document control processes.
- Lead and support Change Control.
- Act as a key contact for quality issues, Non-conformances (NCs), and Corrective and Preventive Actions (CAPAs).
- Maintain and update the company’s product configuration files.
- Collaborate with the QA Manager to prepare for and contribute to internal and external audits.
- Assist in designing and testing (Software and system-level testing) of new designs.
- Assist in analysing test data, summarising results, and generating test reports.
- Assist in risk management techniques such as Hazards Analysis, FMEA & FTA.
- Web page, d-base and other electronic record creation &/or maintenance.
Required experience:
- Minimum 1 year of experience in a similar role, ideally in a medical device company.
- Engineer, degree-qualified in electronics, mechatronics or similar.
- Excellent technical communication and documentation skills.
- Ability to build relationships across cross-functional teams.
- Receptive to feedback and committed to personal growth
- Strong self-motivation and a can-do attitude.
- Tertiary qualification in Science, engineering or a related discipline.
- Microsoft Office skills
Preferred experience:
- Medical device experience (e.g. regulatory environment, safety standards, testing).
- Mechanical and/or electrical CAD (e.g. Solidworks, Altium).
If you are interested in this offer, please send us your CV and a cover letter to
careers@micropace.com.au
Micropace Pty Ltd. is an Equal Opportunity Employer.