Quality Assurance Manager

1 day ago


Bayswater North, Victoria, Australia SDI Limited Full time $120,000 - $180,000 per year

Company

We are a Global Business leading the market with Australian made and owned dental restorative products, teeth whitening and small equipment. Founded in 1972, SDI products are now distributed in over 100 countries throughout the world. Our global head office and manufacturing plant is located in Melbourne with overseas branch offices and warehousing in the USA, Brazil and Germany.

  • Ensuring the quality, legal and regulatory compliance of SDI products throughout their lifecycle, from design and development to manufacturing to distribution.
  • Overseeing the implementation and maintenance of a robust quality system (QMS) in accordance with current standards, best practices, legal and regulatory requirements such as ISO 13485, MDSAP, EU MDR, QMSR (US), ARGMD (AU), ANVISA MD Regulations (Brazil), KGMP & MDM&QC standards (South Korea), NMPA's Decree 739 Regulation on Supervision and Management of Medical Devices (China), SOR/ Health Canada), PMD Act (Japan) etc.
  • Accomplishing quality assurance objectives by monitoring, reviewing, and enforcing policies and procedures.
  • Contributing to the development and implementation of Quality systems, policies and strategies.
  • Conducting work in a safe manner and demonstrating a strong commitment to SDI's values of passion, accountability, respect, teamwork and innovation
  • Leads, coordinates, and plans the work within the QA team
  • Coaches and leads QA Team to develop adequate competencies, efficient working methods, optimal use of resources and a stimulating working climate.
  • Maintains accurate up-to-date documentation related to SDI's QMS, including procedures, records, and reports.
  • Provides Quality Assurance input throughout the product development process to ensure quality is built into the design.
  • Implements risk management systems and processes to identify and mitigate potential risks and product quality and safety.
  • Implements and conducts internal audit programs to identify areas for improvement.
  • Prepares for inspections/audits by regulators.
  • Working with R&D, Engineering, Manufacturing and Marketing to ensure that quality is integrated into all aspect of the product lifecycle.
  • Oversees and ensures the following QA activities are up to date, maintained, analysed, trended and reported into Management regularly:

o Customer complaints handling and reporting

o NCR

o CAPA

o Training

o Change control

o Internal audits

o Supplier & Subcontractor audits

o External (3rd party) audits

o Subsidiary audits

o QMS Documentation

o Post Market Surveillance (PMS)
- Assists validation activities across various departments such as Production, R&D and Engineering
- Works with Procurement with supplier qualification and evaluation
- Contributes to Quality strategies for Continuous Improvement across the business
- Collaborates with the Quality Control Manager to train and motivate employees to ensure quality standards are met
- Achieves quality assurance operational objectives by contributing to information analysis
- Stays current on applicable laws and regulations to ensure compliance
- Acts as internal (outside the EU) Person of Responsibility for Regulatory Requirements (PRRC). Key responsibilities of this PRRC include:

o Reviews and approves the conformity assessment of the device's technical documentation before market release.

o Ensuring that the device being released from routine manufacturing have been manufactured in accordance with SDI's QMS procedures and QC release criteria are traceable to the device specification.

o Conducts periodic sampling of batch release documentation.
- The PRRC shall suffer no disadvantage within the business in relation to the proper fulfilment of their duties.
- Supports Top Management in the promotion of SDI Quality policy and objectives.
- Oversees and ensures the following QA activities are up to date, maintained, analysed, trended and reported into Management regularly:

o Customer complaints handling and reporting

o NCR

o CAPA

o Training

o Change control

o Internal audits

o Supplier & Subcontractor audits

o External (3rd party) audits

o Subsidiary audits

o QMS Documentation

o Post Market Surveillance (PMS)
- Assists validation activities across various departments such as Production, R&D and Engineering
- Works with Procurement with supplier qualification and evaluation
- Contributes to Quality strategies for Continuous Improvement across the business
- Collaborates with the Quality Control Manager to train and motivate employees to ensure quality standards are met
- Achieves quality assurance operational objectives by contributing to information analysis
- Stays current on applicable laws and regulations to ensure compliance
- Acts as internal (outside the EU) Person of Responsibility for Regulatory Requirements (PRRC). Key responsibilities of this PRRC include:

o Reviews and approves the conformity assessment of the device's technical documentation before market release.

o Ensuring that the device being released from routine manufacturing have been manufactured in accordance with SDI's QMS procedures and QC release criteria are traceable to the device specification.

o Conducts periodic sampling of batch release documentation.
- The PRRC shall suffer no disadvantage within the business in relation to the proper fulfilment of their duties.
- Supports Top Management in the promotion of SDI Quality policy and objectives.
- Drives a thorough understanding of current Quality policies and objectives throughout the Company



  • Bayswater North, Victoria, Australia ANCA Pty Ltd Full time $90,000 - $120,000 per year

    Quality Assurance Engineer – Defense ManufacturingDrive containment actions, root cause analysis, and corrective measures for recurring issues.Investigate non-conformances and manage quarantine stocks effectively.Collaborate with cross-functional teams to enhance quality systems and continuous improvement initiatives.Ensure compliance with AS9102 and...


  • Laverton North, Victoria, Australia Hickory HR Pty Ltd Full time

    ABOUT USHickory's patented building technology delivers an innovative, technological alternative to the construction of high-rise projects. The Hickory Building System accelerates construction programs by up to 30%, minimising material and energy waste, whilst maximising quality and safety. We blend the best of manufacturing and construction technology,...


  • Bayswater North, Victoria, Australia Belgravia Leisure Full time

    VIC, Head Office - Sth Melb or Bayswater 3153Hybrid workplace -Work from home and officeEnterprise RTO - Captive internal market 5,000+ employeesBase salary plus superAbout The RoleWe are currently looking for a RTO Quality and Compliance Manager to play a lead role in ensuring our products and processes are of the highest quality for our staff and clients...


  • Bayswater North, Victoria, Australia ANCA Pty Ltd Full time $104,000 - $130,878 per year

    Quality Control Engineer CMMJoin a leading global manufacturer in the CNC machinery sector.Utilise your expertise in high precision metrology instrumentation.Drive continuous improvement initiatives and enhance product quality.Be part of a collaborative team dedicated to innovation and excellence.About ANCAANCA is a world-leading designer and manufacturer of...


  • Bayswater North, Victoria, Australia Core Talent Full time $80,000 - $99,000 per year

    Production SupervisorBayswater$80,000 - $90,000 + Super + Career Progression + BenefitsJoin a growing business with a strong reputation in industrial manufacturing.Our client is a leading manufacturer in the industrial tooling sector, known for delivering high-quality components and solutions to clients across a wide range of industries. Based in Bayswater,...

  • Security Risk Manager

    2 weeks ago


    Bayswater North, Victoria, Australia Vicinity Centres Full time $90,000 - $120,000 per year

    We're reimagining the way Australians live, work, and play. We own and manage some of the most recognisable and loved retail destinations across Australia. We're evolving our portfolio into destinations that offer a broad selection of retail, residential, and office spaces. Through our diverse portfolio, data-led decision-making, and nationwide development...


  • Bayswater North, Victoria, Australia SDI Limited Full time $90,000 - $120,000 per year

    Company We are a Global Business leading the market with Australian made and owned dental restorative products, teeth whitening and small equipment. Founded in 1972, SDI products are now distributed in over 100 countries throughout the world. Our global head office and manufacturing plant is located in Melbourne with overseas branch offices and warehousing...

  • Production Engineer

    7 days ago


    Bayswater North, Victoria, Australia PulseWeld Full time $90,000 - $120,000 per year

    About UsWe are a growing and dynamic manufacturer specializing in metal components, air movement system design, pump process systems, and conveyor systems, committed to innovation, efficiency, and sustainable growth. To strengthen our operations team, we are seeking a skilled Production Engineer to drive process improvements and ensure reliable production of...

  • Production Manager

    7 days ago


    Bayswater North, Victoria, Australia RFI Technology Solutions Full time $90,000 - $120,000 per year

    RFI is a global technology solutions company, specialising in wireless coverage and solar power. We have one of the largest, most innovative and experienced wireless and solar solutions teams with dedicated engineers, product managers, manufacturing, logistics and R&D employees.The RoleWe are seeking an experienced, professional Production Manager from a...

  • Management Accountant

    2 weeks ago


    Bayswater North, Victoria, Australia Fresh to Go Foods Pty Ltd Full time $100,000 - $120,000 per year

    ·       Australian owned Market Leading Brand·       Excellent Growth Opportunities·       Attractive Remuneration Package + bonusWith over 30 years expertise Fresh To Go Foods is a leading food manufacturer dedicated to crafting high-quality, ready-made wraps and sandwiches renowned for commitment to quality, innovation and...