QA Manager Anz

Exciting opportunity to step up into a leadership role
- Hybrid and flexible working arrangements
- Competitive Remuneration Package

**_Do you have what it takes to make a difference?_**

If the answer is yes, join our team. Enhance your Quality Assurance experience in a world-leading medical solutions company. Healthcare professionals inspire our wound management, prevention and surgical solutions. Their relentless search for new and better ways to care for patients drives us to innovate making it possible for is to make a difference to the lives of their patients.

Reporting to APAC Quality Affairs Manager based in the Sydney, the role is responsible to lead and execute the overall Quality Assurance activities in accordance with ISO13485 within the Molnlycke business in ANZ region.

**KEY ACCOUNTABILITIES**:

- In accordance with external standards and regulations, support the ANZ organization in implementation, maintenance and improvement of the QMS aligned with applicable internal policies and procedures.
- Establish and implement Mölnlycke global policies and procedures in the local QMS as applicable and in alignment with Global QA.
- Ensure product complaints are initiated, managed and reported as per established procedures.
- Work closely with the RA Manager ANZ and local organization stakeholders and colleagues for efficiency and transparency.
- Ensure certification to ISO13485 is maintained.
- Maintain a thorough working knowledge of QMS requirements and industry best practice.
- Responsible for change controls, document control, non-conformities, CAPA, audits, product/ customer complaint handling and blocking and traceability of stock.
- Support supply chain team to perform distributor and supplier evaluations, assessments and audits to ensure compliance of contracted warehouses and distributors with local and Mölnlycke internal requirements.
- Perform internal audits as lead-auditor.
- Coordinate and lead QMS third party audits.
- Perform quality management review meetings, prepare and coordinate all related activities.

**WHO WE ARE LOOKING FOR**:

- Tertiary qualifications in a science or quality related discipline.
- Trained quality system auditor/lead auditor.
- At least 5 years of work experiences of Quality and Regulatory, preferably from the medical device, pharmaceutical or food industry with experience from the sales and marketing organisation environment.
- Independent self-starter and ability to work independently.
- Ability to communicate effectively, drive execution and collaborate with others.
- Proactive, takes initiative and thinks outside-the-box.
- Demonstrable teamwork skills.
- Ability to build and maintain relationships between key stakeholders.

**OTHER INFORMATION**:

- Office based in Belrose, Sydney region

**WHAT WE HAVE FOR YOU?**
- You will be part of a team that feels like a family within the solid framework of an international company.
- We have values that puts people at the center of what we do.
- A multicultural, ever-changing work environment where you will have an opportunity to share your ideas and are encouraged to take risks and grow.
- You will be coached in your career, both for professional as well as personal development, particularly through an individualised development plan and available qualitative tools.
- Competitive remuneration package, benefits & 5 weeks of vacation leave

**ABOUT MOLNLYCKE**

Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes.

Our headquarters is located in Gothenburg, Sweden and active internationally with 7,800 employees. We are the number one global provider of advanced wound care and single-use surgical products and Europe’s largest provider of customised trays. Customers use our solutions in almost 100 countries and we own operations in more than 40 of them. Our range of medical solutions is designed to enhance performance at every point of care - from the operating theatre to the home.

We specialize in Surgical drapes, Staff clothing, Biogel surgical gloves, Mepilex dressings, Mölnlycke procedure packs (customised sterile packs that include all single use equipment surgical teams need for specific procedures), Laparoscopic surgical instruments, Orthopedic solutions, Dermatology products and Wound healing solutions.