Quality Manager – Tissue-Based Medical Device
Location: Brunswick, VIC 3056
Employment Type: Permanent | Full-Time (40 hours per week)
Work Mode: Primarily on-site (minimum 2 days per week in lab; occasional travel to South Yarra office)
Salary: Up to $135,000 + Super
Target Start Date: March 2026
About the Role
An Australian tissue-based medical device manufacturer is entering its next stage of growth and regulatory expansion.
This role exists to lead the uplift and expansion of the Quality Management System as the business transitions from customer sampling into validated production under ISO 13485 and ISO 22442 standards.
Key Success Factors
* Achieve and maintain ISO 13485 audit readiness including ISO 22442 expansion
* Establish and operate a compliant laboratory environment aligned to medical device standards
* Embed robust design control, validation and supplier quality systems to support scale-up
This is a hands‐on Quality leadership position within a growing medical device programme.
What Success Looks Like (First 3–6 Months)
* Achieve ISO 13485 and ISO 22442 audit readiness
* Establish controlled laboratory operations aligned to the standard
* Qualify and validate equipment and critical processes
* Implement and strengthen design control SOPs for verification and validation
* Build and maintain a compliant training system
* On‐board and audit suppliers
* Lead internal audit programme ahead of external audit cycle
* Support digital conversion of the QMS
Upcoming Focus Areas
* Validation activities, supplier analysis and digital QMS transition
Key Responsibilities
Quality System Leadership
* Own and maintain ISO 13485 QMS expansion to ISO 22442
* Lead document control, CAPA, non‐conformance, complaints, supplier quality, internal audits and management review
* Interface with risk management ISO 14971
* Drive change control and design change processes
Audit & Compliance
* Prepare site for 6‐month audit cycle
* Lead external notified body interactions
* Strengthen internal audit processes
* Maintain training compliance across the team
Laboratory & Production Oversight
* Establish compliant lab operations
* Qualify equipment and oversee process validation
* Review and approve batch documentation
* Support transition toward cleanroom and continuous production
Supplier & External Stakeholder Management
* Qualify and audit suppliers
* Interface with consultants and notified bodies
* Maintain customer‐facing quality communication
Continuous Improvement
* Convert QMS to digital system
* Strengthen validation frameworks
* Support scale‐up into controlled production environment
Reporting Line
Reports to: Chief Operating Officer
Internal stakeholders: Production, CTO, COO
External stakeholders: Suppliers, notified bodies, auditors, consultants, customers
No direct reports initially. Potential to add a Quality Administrator within 6 months.
Candidate Profile
Must‐Have
* Minimum 5 years' experience in medical device quality or regulated manufacturing
* Strong ISO 13485 experience in a hands‐on environment
* Experience with CAPA, supplier quality, validation and audits
* Ability to operate both hands‐on in the lab and at system level
* Customer‐facing communication capability
* Adaptable, pragmatic and solutions‐focused
* Full working rights in Australia
* Available to commence in March 2026
Nice‐to‐Have
* ISO 22442 experience with animal‐derived materials
* Cardiac, implantable or tissue‐based product exposure
* Risk management interface experience ISO 14971
* Experience transitioning QMS to digital platforms
Personal Attributes
* Mature and professional
* Strong relationship builder
* Comfortable in a scaling, evolving environment
* Not rigid, adaptable to change
Why Join?
* Proven market demand and strong growth trajectory
* Established technical team with strong industry insight
* Opportunity to shape and own the Quality function during scale‐up
* Direct impact on life‐enabling medical technologies
* High‐autonomy role with executive visibility
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