About SDIP Innovations

Founded in 2018, SDIP is dedicated to transforming patients' lives with disruptive bioresorbable implants. As a fast-growing start-up, we have achieved exceptional proven results through research, development, and clinical experience. We are redefining bone implant systems at the intersection of our advanced biomaterial platform (JAZBI™) and patient-specific delivery tools. Our next-generation implants are distinguished by superior bone conversion, mechanical properties, and user-friendly delivery systems, enabling surgeons to treat regular to complex bone defects in extremities, pelvis, and spine.

The Role

As Senior Quality Assurance Specialist, you will work closely with the Quality Manager and engineering teams to support the development, implementation, and continuous improvement of the Quality Management System (QMS) in line with ISO 13485 and FDA requirements. You will be hands-on in driving compliance activities, internal audits, CAPA investigations, and production quality assurance, helping ensure our facility maintains a strong state of audit readiness.

This is a pivotal technical role for a highly motivated and detail-oriented QA professional who thrives in a start-up environment and enjoys working cross-functionally.

Key Responsibilities

Support implementation and maintenance of QMS procedures in accordance with ISO 13485 and 21 CFR 820.

Participate in internal audits and support external audit readiness (FDA, ISO, TGA).

Perform document control, record management, and traceability reviews for DMR, DHR, DHF, and QMS records.

Support CAPA, NCR, and deviation investigations: initiate reports, collect data, perform root cause analysis, and track corrective actions to closure.

Conduct QA review of batch records, incoming material documentation, and production quality documentation.

Collaborate with engineering, QC, and production teams to ensure quality is built into the design and manufacturing processes.

Monitor and report on quality metrics and suggest areas for continuous improvement.

Provide QA input into risk assessments (ISO 14971) and change control.

Support the development and execution of Manufacturing Quality Plans.

Assist in training staff on relevant quality procedures and regulatory expectations.

About You

A bachelor’s degree in Biomedical Engineering, Materials Science, Mechanical Engineering, or a related field.

Minimum 3 years of experience in Quality Assurance within a medical device or pharmaceutical manufacturing environment.

Strong understanding of ISO 13485:2016, FDA 21 CFR 820, and ISO 14971.

Hands-on experience in document control, internal audits, CAPA/NCR processes, and production QA activities.

Meticulous attention to detail and strong documentation skills.

Ability to work collaboratively across multidisciplinary teams.

Excellent written and verbal communication skills.

Proactive and resourceful problem solver, with a strong sense of ownership and accountability.

Nice to Have

Experience working in a start-up or scale-up environment.

Familiarity with validation protocols, equipment qualification, or supplier quality management.

Exposure to EU MDR or TGA regulatory pathways.

Employer questions

Your cover letter should address the following questions:

How many years of experience do you have in medical device quality control and quality assurance (QA) roles?

Have you completed a related qualification?

Have you worked in a role that requires a sound understanding of Good Manufacturing Practices (US FDA GMP) and/or ISO13485?

How experienced are you in developing required documents for medical devices according to regulatory requirements?

How confident are you in generating, routing, releasing, implementing and overseeing quality documents and guidelines?

Join Us at SDIP
If you're passionate about quality, innovation, and improving patient outcomes, and want to grow your career in a high-impact medical device start-up, apply now!

Note: Applicants must have full working rights in Australia. Sponsorship is not available for this role.