Senior Quality Assurance Manager – Biological Medical Devices

CS Executive Group; Sydney; On-site; AUD 140,000 - 210,000; Full time

Benefits offered by this job

Relocation assistance

Competitive salary

Superannuation

Job summary

CS Executive Group is seeking a Senior Quality Assurance Manager for a regional NSW site in Australia, focused on regulated biological medical devices. The role offers a genuine pathway to Head of Quality with relocation assistance available and the chance to influence quality strategy across manufacturing and product development.

You will lead a Quality organization, drive ISO 13485 compliance, manage audits, CAPA and change control, and partner with Manufacturing, R&D and Supply Chain to

Qualifications

• Demonstrated hands-on ISO 13485 experience in a medical-device manufacturing environment.
• Extensive QA/QMS leadership in highly regulated manufacturing.
• Strong knowledge of GMP, regulatory compliance, risk management, validation, CAPA, change control and audits.
• Experience leading and developing Quality teams, building capability and accountability.
• Track record of improving, integrating or harmonising Quality systems and processes.
• Strong stakeholder engagement skills and ability to work with technical, operational and executive teams.
• A tertiary qualification in Science, Engineering, Biotechnology, Biomedical Science or related discipline.

Responsibilities

• Lead, develop and mentor the Quality team, fostering a collaborative, accountable and continuous improvement culture.
• Maintain, strengthen and integrate Quality Management Systems in accordance with ISO 13485 and regulatory requirements.
• Provide leadership across Quality Assurance, Quality Control and Quality systems activities.
• Oversee internal and external audits, regulatory inspections and ongoing audit readiness.
• Lead investigations, non-conformance management, root cause analysis, CAPA and change control processes.
• Provide Quality oversight of manufacturing operations, process and equipment validation, supplier Quality and product release activities.
• Strengthen risk management, documentation, training and Quality performance reporting.
• Partner with Manufacturing, Product Development and Supply Chain to support process improvements, product development and operational effectiveness.
• Identify opportunities to streamline processes, improve system effectiveness and embed a proactive, risk-based approach to Quality.
• Contribute to the strategic development of the Quality function and the organisation's longer-term growth objectives.

Skills

ISO 13485

GMP

CAPA

Change control

Audit management

Quality leadership

Regulatory compliance

Stakeholder engagement

Biological medical devices

Education

Science/Engineering/Biotech/ Biomedical Science degree

Job description

Senior Quality Assurance Manager – Biological Medical Devices

GENUINE PATHWAY TO HEAD OF QUALITY | ISO 13485 | RELOCATION ASSISTANCE

REGIONAL NSW | COMPETITIVE SALARY + SUPERANNUATION | RELOCATION ASSISTANCE AVAILABLE

An exciting opportunity has arisen for an experienced Senior Quality Assurance Manager to join an innovative Australian manufacturer operating in the highly specialised field of biological materials for medical devices and healthcare applications.

Our client is an established and growing business specialising in the development and manufacture of biomaterials used in medical and healthcare applications. With continued investment in its people, systems and manufacturing capabilities, the organisation is entering an important phase of growth and development.

We are seeking an accomplished Quality professional who can combine strong technical expertise with effective people leadership, sound commercial judgement and a commitment to building a high-performing Quality function.

This position offers a genuine pathway to Head of Quality. For an exceptional candidate with the appropriate strategic leadership experience and capabilities, our client is also prepared to consider a direct appointment at Head of Quality level.

GENUINE PATHWAY TO HEAD OF QUALITY | ISO 13485 | RELOCATION ASSISTANCE

REGIONAL NSW | COMPETITIVE SALARY + SUPERANNUATION | RELOCATION ASSISTANCE AVAILABLE

An exciting opportunity has arisen for an experienced Senior Quality Assurance Manager to join an innovative Australian manufacturer operating in the highly specialised field of biological materials for medical devices and healthcare applications.

Our client is an established and growing business specialising in the development and manufacture of biomaterials used in medical and healthcare applications. With continued investment in its people, systems and manufacturing capabilities, the organisation is entering an important phase of growth and development.

We are seeking an accomplished Quality professional who can combine strong technical expertise with effective people leadership, sound commercial judgement and a commitment to building a high-performing Quality function.

This position offers a genuine pathway to Head of Quality. For an exceptional candidate with the appropriate strategic leadership experience and capabilities, our client is also prepared to consider a direct appointment at Head of Quality level.

The Opportunity

Reporting to a senior executive, you will play a pivotal role in strengthening and integrating the organisation's Quality Management Systems, ensuring regulatory compliance and supporting operational excellence across manufacturing and product development activities.

Working closely with Manufacturing, Product Development, Supply Chain and other key stakeholders, you will lead and develop the Quality team, drive continuous improvement and ensure that Quality systems and practices support the organisation's current operations and future growth.

This is an opportunity to influence the direction of the Quality function, contribute to business-wide decisions and build the systems, processes and team capabilities required for the next stage of development.

Key Responsibilities

• Lead, develop and mentor the Quality team, fostering a collaborative, accountable and continuous improvement culture.

• Maintain, strengthen and integrate Quality Management Systems in accordance with ISO 13485 and other applicable regulatory requirements.

• Provide leadership across Quality Assurance, Quality Control and Quality systems activities.

• Oversee internal and external audits, regulatory inspections and ongoing audit readiness.

• Lead investigations, non-conformance management, root cause analysis, CAPA and change control processes.

• Provide Quality oversight of manufacturing operations, process and equipment validation, supplier Quality and product release activities.

• Strengthen risk management, documentation, training and Quality performance reporting.

• Partner with Manufacturing, Product Development and Supply Chain to support process improvements, product development and operational effectiveness.

• Identify opportunities to streamline processes, improve system effectiveness and embed a proactive, risk-based approach to Quality.

• Contribute to the strategic development of the Quality function and the organisation's longer-term growth objectives.

About You

You will be an experienced Quality leader with a strong background in regulated biological medical device manufacturing and a demonstrated ability to develop people, strengthen systems and influence stakeholders across an organisation.

To be successful, you will bring:

• Demonstrated, hands-on experience with ISO 13485 Quality Management Systems within a medical-device manufacturing environment — essential.

• Significant experience in Quality Assurance, Quality Management or Quality Systems leadership within a highly regulated manufacturing environment.

• Strong working knowledge of GMP, regulatory compliance, Quality risk management, validation, CAPA, change control and audit management.

• Experience leading and developing Quality teams, with the ability to build capability, accountability and positive working relationships.

• A track record of improving, integrating or harmonising Quality systems and processes.

• Strong stakeholder engagement skills and the ability to work collaboratively with technical, operational and executive teams.

• A relevant tertiary qualification in Science, Engineering, Biotechnology, Biomedical Science or a related discipline.

Experience with biologically derived materials, tissue-based medical devices or other complex biological manufacturing processes would be highly regarded.

Exposure to TGA, FDA, EU MDR, ISO 9001 or ISO 22442 requirements would also be advantageous.

For candidates being considered at Head of Quality level, we will be looking for demonstrated strategic leadership, broader organisational influence and the capability to shape the future direction of the Quality function.

Why Consider This Opportunity?

• Genuine career progression: A clear pathway to Head of Quality, with direct appointment at that level possible for an exceptional candidate.

• Meaningful leadership influence: The opportunity to shape Quality strategy, strengthen systems and contribute to business-wide decisions.

• Innovative industry: Work with specialised biomaterials used in medical devices and healthcare applications.

• Growing Australian business: Join an organisation investing in its people, capabilities and future development.

• People and culture: Lead and develop an established Quality team and help build a strong, collaborative Quality culture.

• Relocation support: A competitive remuneration package and tailored relocation assistance for the successful candidate.

Location – Regional NSW

This is a site-based position located at a major regional centre in Central Western NSW offering a relaxed lifestyle, established schools, healthcare facilities, sporting and recreational opportunities, and a strong sense of community.

For candidates considering a move from Sydney, Melbourne, Brisbane, other Australian locations or New Zealand, relocation assistance is available and can be tailored to individual circumstances.

Applicants must have unrestricted working rights in Australia. Employer-sponsored visas are not available for this position.

All applications will be treated in strict confidence.