Quality Assurance and Regulatory Associate

PURPOSE OF THE JOB

Position Purpose

A niche, standalone role within a global organisation’s close-knit ANZ team

ZOLL Medical is a global leader in acute critical care and resuscitation technologies, with operations spanning over 140 countries. Within the Australia and New Zealand region, ZOLL operates on a smaller scale — a compact, agile team supported by a central office and warehouse based in St Leonards, Sydney. Despite being part of a global enterprise, the ANZ business functions much like a small local office, where every role has meaningful visibility and impact.

We are seeking a locally based, experienced WHS and QA professional to join our team in a part-time capacity (2.5 days per week). This is a specialist, standalone position, ideal for someone who thrives in a hands-on, generalist environment and is looking for flexibility, autonomy, and the ability to directly influence health, safety, and quality outcomes across a close-knit operation.

This role is critical in ensuring compliance with Australian and New Zealand WHS legislation and quality standards, while also contributing to the broader organisational culture of accountability, risk management, and continuous improvement. The successful candidate will be responsible for owning and leading local QA and WHS frameworks, adapting global policies to local requirements, and engaging directly with staff across technical services, operations, and senior leadership.

This is a high-impact opportunity for a professional seeking to apply their expertise in a smaller, more personable work environment, while still aligning with the standards and systems of a globally recognised medical device organisation.

About ZOLL Medical

ZOLL Medical is a global leader committed to developing and providing life-saving resuscitation and acute critical care technology. Our innovative products and services empower health professionals and emergency responders to save lives in complex and critical situations. With a dedication to excellence, patient outcomes, and advancing technology, ZOLL is transforming emergency medical care worldwide.

ZOLL is focused on improving outcomes with novel resuscitation and acute critical care technology. Our medical products and software solutions help clinicians, EMS and fire professionals, lay rescuers, and the military provide lifesaving care every day. ZOLL delivers technology that advances emergency care and benefits patients.

RESPONSIBILITIES

Key Responsibilities

              Australian Legal and Regulatory Compliance

• Ensure ZOLL Medical’s operations in Australia meet the requirements of the Work Health and Safety Act 2011 (Cth) and relevant state/territory-based WHS laws, including SafeWork NSW, WorkSafe VIC, WorkSafe QLD, and others as applicable.
• Monitor changes in Australian legislation, codes of practice, and industry standards, and provide advice to local leadership regarding their implications.
• Liaise with relevant government agencies regulators and external consultants within Australia to ensure alignment and compliance (e.g. Safe Work Australia, TGA, ISO certifying bodies).
• Ensure the Company Director and senior managers are aware of their duties as Officers under Section 27 of the WHS Act, and provide appropriate support, resources, and documentation to meet their obligations.
• Prepare the business for internal and external audits and represent the company in inspections and WHS compliance reviews conducted by Australian regulators.

             WHS Strategy, Systems and Operations

• Develop and implement a local WHS strategy that supports ZOLL Medical’s commitment to creating a safe and healthy workplace, aligned to Australian legal obligations and cultural expectations.
• Design, implement, and manage a WHS Management System (WHSMS) that is robust, auditable, and appropriate to the business’s risk profile and operations.
• Conduct and document risk assessments, safety audits, site inspections, and compliance monitoring across all Australian operations.
• Lead the development and delivery of local safety training, onboarding modules, toolbox talks, emergency drills, and employee education programs to ensure awareness and engagement with WHS responsibilities.
• Act as a key escalation point for safety concerns and incidents, ensuring that investigations are carried out and reported appropriately to regulators, with full documentation and response management in line with Australian standards.
• Carry out Staff Safety Inductions

              Quality Assurance

• Manage and maintain a Quality Management System (QMS) that supports compliance with ISO 9001, ISO 13485, and TGA expectations specific to the Australian medical device sector.
• Write, update, and control all QA documentation to ensure that it is owned and governed locally, including SOPs, work instructions, corrective actions, preventive actions (CAPA), deviation reports, and quality records.
• Conduct internal QA audits and oversee external audit preparedness, coordinating with relevant business units to drive a culture of accountability and quality.
• Work closely with the ANZ Senior Management, Operations, and Service teams to ensure quality standards are embedded into all internal processes and external service delivery across Australia and New Zealand.
• Maintain National Pricing Catalogue for Contracts.

         Risk Management, Governance & Manager Due Diligence

• Support the development and management of a comprehensive risk management framework for the Australian business, with WHS and QA risks formally registered and reviewed regularly.
• Provide advice and support to the Company Director and Officers of the business to ensure they meet their legal duty of due diligence in relation to workplace safety, quality compliance, and audit readiness.
• Document and report risks, actions, incidents, and regulatory obligations in a transparent, structured manner that can be reviewed at board and leadership level.
• Ensure the business maintains robust, real-time documentation that can support legal defensibility in the event of incident investigations, legal action, or insurance claims.
• Provide input into governance structures such as risk registers, policy reviews, and WHS/QA reporting packs for leadership meetings.

        Policy Development and Local Ownership

• Write, maintain, and review all WHS and QA policies, manuals, and procedural documents used by Australian staff, ensuring alignment to local legislative and operational requirements.
• Maintain the Australian Policy Register, managing version control, approval workflows, expiry schedules, and historical change logs.
• Ensure all documentation — including price guides, service instructions, operational checklists, and reporting tools — are written for and governed by Australian standards only.
• Prevent the direct application of international templates or APAC/US policies that have not been assessed and adapted for legal, operational, and cultural appropriateness within Australia.

        Safety Culture & Continuous Improvement

• Promote a safety-first mindset and foster a culture of shared responsibility, continuous improvement, and proactive risk management.
• Lead WHS committee participation or engagement forums and maintain a visible presence as a trusted advisor and champion for safety and quality across the Australian business.
• Identify gaps, trends, and opportunities for improvement using audits, employee feedback, and incident data, and implement meaningful, measurable improvements.

          New Zealand Framework

• While this role is based in and reports through Australia, it also supports ZOLL Medical’s New Zealand operations in partnership with the NZ Manager.
• Quality and safety frameworks implemented in New Zealand must meet the Health and Safety at Work Act 2015 (NZ) and align with NZS ISO 9001 and NZS ISO 13485 standards.
• This role ensures consistency across both countries while maintaining compliance with the distinct legal and regulatory environments in each.
• Documentation and audit processes will be tailored for New Zealand requirements and supported locally by this role, under Australian governance.

       Ad-Hoc Responsibilities (as needed)

• Handling Customer Enquiries
• Credit Note Process/ Credit Authorisation
• Product Returns Process
• Sending Quotes to Customers
• Travel
• Stationary/Office Supplies management
• Back up in warehouse – When urgently required
• Acceptance Testing of AED units (AED+ & AED3) - When urgently required
• Assist in function set ups and social initiatives

Required Skills and Experience

• Minimum 3–5 years' experience in a WHS or QA function with Australian legislative experience.
• Proven understanding of WHS laws in Australia and related frameworks (SafeWork Australia, Model Codes of Practice).
• Familiarity with quality standards including ISO 9001, ISO 13485, and TGA medical device compliance.
• Demonstrated experience writing and managing Australian WHS and QA documentation and systems.
• Strong incident investigation, risk management, and audit preparation capabilities.
• Ability to influence and educate senior leaders on their legal responsibilities and risk exposure under Australian law.
• Certificate IV WHS or equivalent required; formal audit or quality systems training highly desirable.

Why Join ZOLL Medical ANZ?

• Make a Real Impact
  Join a global organisation whose mission is to improve and save lives through innovative medical technology and solutions.

• Purpose-Driven Culture
  Be part of a team where patient outcomes, quality, and safety are at the core of everything we do.
• Collaborative and Supportive Environment
  Work in a culture that values open communication, cross-functional collaboration, and a strong sense of teamwork across ANZ and globally.

• Strong ANZ Presence
  As a key member of the ANZ team, you’ll have the opportunity to influence local practices while contributing to global quality and WHS standards.

• Commitment to Excellence
  Join a company that upholds the highest standards in ISO certification, regulatory compliance, and continuous improvement — both in Australia and New Zealand.

• Career Growth and Development
  Access professional development, training, and leadership support to grow and advance your career within a growing and reputable organisation.

• People-First Approach
  At ZOLL, we value and support our employees with flexibility, recognition, and a strong focus on well-being and work-life balance.

• Innovation and Technology
  Work with leading-edge medical products and solutions that are shaping the future of emergency care and patient monitoring.

REQUIREMENTS

Required Skills and Experience

• Minimum 3–5 years' experience in a WHS or QA function with Australian legislative experience.
• Proven understanding of WHS laws in Australia and related frameworks (SafeWork Australia, Model Codes of Practice).
• Familiarity with quality standards including ISO 9001, ISO 13485, and TGA medical device compliance.
• Demonstrated experience writing and managing Australian WHS and QA documentation and systems.
• Strong incident investigation, risk management, and audit preparation capabilities.
• Ability to influence and educate senior leaders on their legal responsibilities and risk exposure under Australian law.
• Certificate IV WHS or equivalent required; formal audit or quality systems training highly desirable.
• Strong communication skills.
• Attention to detail.
• Flexible