Quality Assurance Manager

3 weeks ago


Auckland City, New Zealand 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



  • Auckland City, New Zealand Restaurant Brands Full time

    Quality Assurance Manager Restaurant Brands (RBL) is a corporate franchisee and specialises in managing multi-site branded food retail chains. Restaurant Brands is listed on the New Zealand Stock Exchange and currently has 277 stores across New Zealand for KFC, Pizza Hut, Carl's Jr, and Taco Bell. We employ over 3,500 staff across NZ and serve over 60,000...


  • Auckland City, New Zealand Tyler Wren Full time

    Supportive team environment - Grow your skill set in the compliance space - 6 Month contract Our client, a large well-established bank is looking to add a Quality Assurance specialist to their team on a 6-month fixed term contract. You will work in a rewarding role with a supportive team environment and report to the Senior Manager. The role is responsible...


  • Auckland City, New Zealand Icon Full time

    Building & Construction - Other - Auckland, NZ - Permanent / Full Time - Coordinate QA, facilitate communication & support processes for project success - Icon NZ is an established builder with a healthy pipeline of work - Opportunity for career development and personal growth **Why Icon?** The Icon Group, an Australian construction conglomerate comprised...

  • Quality Assurance

    7 months ago


    Auckland City, New Zealand Scitex Recruitment Full time

    Calling all ice cream lovers! Gain valuable dairy industry experience. - Join a dynamic team dedicated to crafting the highest quality products. - Supportive inclusive environment with excellent job security. Our client is passionate about crafting high-quality ingredients for ice cream. With a focus on quality, innovation, and continuous improvement, they...


  • Auckland City, New Zealand Lawson Williams Consulting Group Full time

    Quality voice across New Zealand Manufacturing - High reputable brands - Join a close team with a positive work culture **About the company** *** This organisation is passionate about delivering a diverse range of pet food products to international and national markets which has resulted in a highly recognised and reputable pet food brand. They look to...


  • Auckland City, New Zealand Danone Full time

    About the job As a **Quality Assurance Coordinator**,** **you will join our QA team of 4 reporting to the Quality Assurance in-Process Manager - part of the wider Quality and Food Safety team, located at our Auckland production facility. This is a **permanent full-time opportunity **working **Monday - Friday** **8.30am - 5pm**, with the main purpose of...


  • Auckland City, New Zealand Vitaco Full time

    **Quality Assurance Specialist** **About us | Mō mātou** At Vitaco 'We Care, We Act, We Succeed'. We are globally renowned for manufacturing the highest quality natural health products, distributing to over 30 countries across 5 continents. People who work for Vitaco enjoy a fast-paced industry and relate to our vision of “Empowering healthier...


  • Auckland City, New Zealand Lion Pty Ltd Full time

    10 Sep 2024- Auckland, North Island, NZAt Lion, we're not just about brewing great beer; we’re about creating unforgettable experiences. We also believe in doing the right thing for the long term, so we never settle, always leading the way for things we truly care about in our environment, communities, and workplace. As our **Quality Assurance Leader**,...


  • Auckland City, New Zealand Michael Hill Full time

    **Quality Assurance Administrator** In 1979, Sir Michael Hill and his wife Christine opened their first jewellery store with a simple yet groundbreaking vision: to make fine jewellery accessible to everybody. 40 plus years later, we remain committed to creating quality jewellery for our customers to cherish for a lifetime. From 1979 through today and into...


  • Wellington City, New Zealand New Zealand Ministry of Justice Full time

    **Manager Planning, Quality and Assurance** **Permanent Full Time** **Wellington Based** **_ _** **Te whiwhinga mahi/The Opportunity** The Manager Learning, Planning and Quality Assurance is a key role in the OSD Learning and Development Leadership Team. This role leads a team who deliver quality assurance and continuous improvement across OSD learning...


  • Auckland City, New Zealand Bidfood Ltd Full time

    The Quality Assurance Officer plays a critical role in ensuring the quality, safety, and compliance of products. This position involves inspecting, testing, and advising on various aspects of production to maintain high standards and regulatory compliance. **Key Responsibilities**: - Conduct routine inspections produce to identify quality issues and other...


  • Auckland City, New Zealand Douglas Pharmaceuticals Full time

    **About the role** Our Quality Assurance (QA) team are responsible for the review of batch manufacturing and packaging documentation, analytical data/systems, validation protocols and reports, coordination of complaint follow-up and various investigation teams, co-ordination of periodic product reviews. QA ultimately ensure we are releasing products that...


  • Auckland City, New Zealand Technical Recruitment Solutions Full time

    **Quality Assurance Assistant** - South/East Auckland location - Some flexibility in work hours - Supportive leadership team **The Company**: Our client is a New Zealand owned business based in South Auckland. Founded 20 years ago, they are now a well-established business providing a range of agricultural products to their strong customer base. **The...


  • Auckland City, New Zealand Goodman Fielder Full time

    The Company At Goodman Fielder our purpose is simple. It's about making everyday food better for everyone. Goodman Fielder is a leading global food company, and the custodian of a host of iconic Kiwi brands like Meadow Fresh, Puhoi Valley, Molenberg, Natures Fresh and Freya's that generations of New Zealand have grown up with and put in their supermarket...


  • Auckland City, New Zealand Technical Recruitment Solutions Full time

    Exciting and diverse range of products - Passionate and supportive management team - Great track record for staff retention **The Company**: A highly successful and rapidly expanding food manufacturer based near Mt Wellington in Auckland is looking to source new talent to join and support their quality team. Providing contract manufacturing services, retail...


  • Wellington City, New Zealand New Zealand Government Full time

    Permanent Full Time Wellington Based Te whiwhinga mahi/The Opportunity The Manager Learning, Planning and Quality Assurance is a key role in the OSD Learning and Development Leadership Team. This role leads a team who deliver quality assurance and continuous improvement across OSD learning delivery through effective workplan management, evaluation and...

  • Quality Assurance Lead

    7 months ago


    Auckland City, New Zealand H2R Consulting Full time

    **Location**: Auckland Type: Permanent / Full Time Reference: 853143 Are you passionate about fostering positive and equitable outcomes for your community? Are you an experienced Project/Contracts Manager keen to make a difference? We want to hear from you! - Work for a values-driven organisation making a real difference in the community. - Highly...


  • Wellington City, New Zealand Tyler Wren Full time

    WORK FROM ANYWHERE IN NZ! - Supportive management - Positive team culture We are assisting a well-established banking institution with recruiting a Quality Assurance Advisor to join their team on a fixed-term basis (6 months). As a QA Advisor, you will develop and deliver a program of credit assurance reviews in line with risks faced by the business during...


  • Wellington City, New Zealand New Zealand Government Full time

    This is a unique opportunity to contribute to the future of cash distribution in New Zealand. A role with a focus on operational excellence as we move to the future, which includes changes to our infrastructure, systems and tools, and ways of working.Te tūranga - The roleThe Manager Product Quality and Assurance is a critical role within the Money and Cash...


  • Auckland City, New Zealand Jack Link's New Zealand Ltd Full time

    **Company Description** When it comes to being wild, we know a thing or two. We’re not afraid of trying something new or the hard work it takes to make it happen. It’s in our DNA. We’ve turned a family recipe into a snacking category. To help us on our journey we are looking for a **Quality Assurance Specialist**to join our awesome team based in...