Senior Quality Specialist
Thermo Fisher Scientific
Melbourne, Victoria, Australia
3d ago

Job Description

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation.

As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Thermo Fisher Scientific in ANZ

Our growing team of 1200+ employees work together to deliver world-class science products and solutions to a wide range of key markets.

  • With commercial, manufacturing and distribution sites scattered across Australia and New Zealand, including Melbourne, Brisbane, Sydney, Auckland, Adelaide, Newcastle, and Perth, our scope covers life sciences;
  • specialty diagnostics; food, dairy & beverage; environmental & industrial; healthcare and;, analytical instruments including commercial, customer service, technical service, supply chain, finance and operations.

    Job Title : Senior Quality Specialist

    Position Location : Scoresby

    How you'll make an impact :

    Reporting to the Quality and Regulatory Affairs Manager - the Quality Assurance (QA) Specialist is responsible for driving and providing leadership for Thermo Fisher Scientific ANZ’s Quality Management Systems to ensure organizational compliance and best practices.

    The QA Specialist will play an integral role in driving our mission to guide, partner, safeguard and embed Quality and Regulatory practices.

    What will you do?

    Drive and maintain a QA program for monitoring quality activities in line with the requirements of ISO 9001 : 2015 for Thermo Fisher Scientific ANZ.

    Maintain strong global trade compliance structures including the management of import and export permits as well as chemical compliance.

    Lead key Quality Assurance projects across ANZ.

    Coordinate and oversee an internal and external audit program across ANZ.

    Oversee and control documentation and records, leveraging systems such as MasterControl.

    Support the organization’s continuous improvement by guiding the business through appropriate root cause analysis of critical items raised under the Corrective and Preventative Action system.

    Develop protocols to foster a Quality Culture’ with a focus on business excellence and improvement.

    Aid in the development and update of key Policies, Procedures and Work Instructions.

    Drive and manage customer concerns, manufacturer correspondence and quality trend analysis.

    Set up lead and lag quality indicators, dashboards, and other analytics to give senior management clear visibility of performance.

    Provide expert advice across the Thermo Fisher Scientific ANZ organization on national and international standards that impact the organization.

    Education :

    Bachelor’s Degree (or equivalent) in a Business or Scientific discipline

    Experience :

    Strong knowledge of, and experience with, ISO 9001 : 2015. Knowledge and experience with ISO 13485 : 2016, ISO 31000 : 2018, ISO 17025 : 2017, import and export permits, and global trade compliance and / or chemicals.

    Internal auditor qualifications. Lead auditor qualifications would be highly regarded as well as strong experience auditing internally and externally.

    Experience mapping processes and workflows.

    Knowledge of medical devices, life sciences and / or industrial / scientific equipment.

    What will put you ahead of the competition?

    Resilience

    Strong communication skills and collaboration

    Ability to plan, prioritise and optimize work processes

    What’s in it for you?

    A competitive salary and performance related bonus structure

    Access to Thermo Fisher’s global University

    Exposure to market leading cutting edge technologies.

    Development opportunities as part of a rapidly growing global organisation

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