Quality Assurance Manager

4 days ago

Sydney, Australia Thermo Fisher Scientific Full time

When your part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world.

**Job Title: Quality Assurance Manager**

**Location: Melbourne, Perth, Brisbane, Sydney, and Auckland**

**Reporting To: Senior QARA Manager-ANZ**

**Number of Direct Reports: 1-3**

**How you'll make an impact**:
The Manager Quality Affairs, ANZ is responsible for providing quality system leadership and support across the Thermo Fisher Scientific ANZ organisation to ensure organisational compliance and to identify ways to improve ANZ quality systems.

**What will you do?**

This position is QA lead in Thermo Fisher Scientific ANZ, will maintain and improve the Quality Management System (QMS), develop, and maintain QA talents in ANZ across 5 sites in Australia and New Zealand, and will lead and drive QA team to ensure they are adequately resourced to:

- Define, implement, and execute effective quality strategies and processes according to, but not limited in TGA/MedSafe Medical Device & In Vitro Diagnostic Device regulations, ACMR RCM marking for Thermo Fisher Scientific ANZ excluding Divisional Manufacturing Operations with the goal of exceeding compliance, organisation risk and organisation commercial opportunities.
- Provide expert advice across the Thermo Fisher Scientific ANZ organisation, for all matters pertaining to quality assurance according to, but not limited in TGA/MedSafe Medical Device & In Vitro Diagnostic Device regulations, ACMR RCM marking.
- Proactively partner with key business stakeholders to understand key business matters and any areas of impact from a quality perspective.
- Establish and maintain of Quality Management System (QMS) for the regulated products, especially Medical Device & In Vitro Diagnostic Device, supplied in ANZ according to ISO 9001/ISO 13485 and ANZ regulatory requirements
- Lead, drive and oversee the resource organisation and activities coordination for external audits and regulated audits if needed.
- Supply professional guidance or training to cross-functional teams to implement quality assurance work, including quality documents and records.
- Maintain and improve Complaint Management, CAPA, NC Management systems, etc., especially for Medical Devices / In Vitro Diagnostic Devices post-market vigilance control.
- Lead, coach and develop a high performing QA team within the ANZ region

**How will you get here?**

**Education**:

- A Bachelor’s Degree (or equivalent) in Scientific discipline

**Experience**:

- 10+ years of experience in Quality Assurance related to TGA/MedSafe Medical Device & In Vitro Diagnostic Device regulations, ACMR RCM marking.
- 2-3 years of managerial experience
- Strong leadership skills with the ability to engage key business stakeholders to achieve required results.
- Organisational skills with an ability to prioritise time effectively and meet agreed deadlines.
- Strong communication skills with an ability to develop strong working relations and influence cross-functional teams across a complex environment with multiple business units and a broad product range.
- Exemplary analytical skills with meticulous attention to detail and strong execution.
- Experience in all elements of QMS and change management
- Proficiency in routine IT software packages.

**Other Job Requirements**:

- Ability and willingness to travel as required up to 10-15%
- Maintaining the Quality Management System under the direction of the Global Quality Team

**What’s in it for you?**
- A competitive salary and performance related bonus structure
- Exposure to market leading cutting-edge technologies.
- Development opportunities as part of a rapidly growing global organisation

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $40 billion and approximately 110,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner, and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market, and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services

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