Quality Assurance Manager

5 days ago

Australia Hollister Incorporated Full time

About the Role:

The Quality Assurance Manager will provide leadership and vision as part of a cross-functional Plant Leadership Team, striving for a dynamic Culture of Quality to continuously improve our products, processes, and Quality Management System (QMS) to best fulfill our Mission and Vision.

Key Responsibilities:

  • Directly oversee the activity of the QA department and staff, generating and maintaining a plan for the professional development and coaching of all direct reports, including annual goal setting.
  • Develop and maintain an overall strategy for the QA function, ensuring communication to key stakeholders for alignment.
  • Responsibility for developing, implementing, and maintaining the QMS for the organization's products and processes, ensuring audit readiness and compliance with required standards, regulations, and company procedures.
  • Quality oversight for raw materials, packaging components, in-process, and finished goods product release.
  • Quality oversight for change control, complaints, internal audit, risk management, notified body/health authority external audits.
  • Quality oversight for validation activities linked to process, equipment, and computer systems.
  • Quality oversight for the introduction of changes to existing products and of new innovative products.
  • Support and lead on the site's operational excellence program, ensuring the quality function works towards efficient and effective processes.
  • Provide QA technical direction and guidance to achieve company objectives.
  • Responsibility for preparation and management of the QA operating budget in conjunction with the Operations and Finance functions.
  • Collaborate with manufacturing to ensure achievement of existing quality levels of manufactured products and seek methods to continually improve quality outcomes, including leading on cost of quality initiatives.
  • Decision-making authority with respect to product quality in consultation with key stakeholders.
  • Participate in Plant Leadership Meetings as required.
  • As part of Hollister's Global Quality Leadership Team (QLT), the position holder will attend QLT meetings as required.
  • Represent the site as Management Representative/Authorized Representative/Person Responsible for Regulatory Compliance as outlined in Medical Device regulations if required.

Requirements:

  • 8-12 years of overall experience, with 5+ years in a Medical Device/Pharma Industry in a Quality Leadership role that includes personnel and Quality System leadership.
  • Third Level degree in Quality/Science/Engineering or a related discipline is required, with an advanced degree desirable.
  • Thorough knowledge of Quality Management system elements and associated regulatory requirements (ISO 13485, ISO 14971, FDA 820.30, MDD/MDR, etc.).
  • Knowledge of internal & external audit management with proven experience in representing a company in interactions with notified body/Regulatory agencies.
  • Good working knowledge of continuous improvement and root cause problem solving in a manufacturing setting.
  • Demonstrated ability to project manage and execute tasks in a timely and efficient manner.
  • Must be able to communicate (both written and verbal) at all levels of the organization and with customers, suppliers, and regulatory agencies.
  • Good interpersonal skills with the ability to work as part of a cross-functional team.
  • Excellent analytical skills with an ability to define problems, analyze through data collection/fact finding, and draw valid conclusions in a timely manner.
  • Have a continuous improvement mindset and demonstrated change management skills.

  • Quality Assurance Manager

    1 week ago

    Australia Royal Australian Mint Full time

    Job DescriptionQuality Assurance & Control (Manufacturing, Transport & Logistics)The Royal Australian Mint is seeking a highly skilled Quality Assurance Manager to champion quality assurance of the Mint's manufacturing operations, driving and supporting a culture of quality and compliance.Key Responsibilities:Lead the Quality Function: Develop and improve...

  • Quality Assurance Manager

    7 days ago

    Australia Frontline Recruitment Group Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Manager to join our team at Frontline Recruitment Group. As a Quality Assurance Manager, you will play a lead role in ensuring our client's hospital meets the National Safety and Quality Health Service (NSQHS) standards.Key ResponsibilitiesLead and coordinate hospital audits and improvement...

  • Quality Assurance Manager

    7 days ago

    Australia Frontline Recruitment Group Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Manager to join our team at Frontline Recruitment Group. As a Quality Assurance Manager, you will play a lead role in ensuring our clients meet the highest standards of quality and safety.Key ResponsibilitiesLead and coordinate quality audits and improvement projectsProvide effective leadership...

  • Quality Assurance Manager

    6 days ago

    Australia Evolvescientific Full time

    About EvolvescientificEvolvescientific is a leading food packaging manufacturer based in the South Eastern suburbs of Melbourne. We are seeking a highly skilled Quality Manager to join our team on an initial 3-6 month contract with a view to transition to permanent.About The RoleWe are currently seeking a Quality Manager to lead and manage production quality...

  • Quality Assurance Manager

    3 days ago

    Australia DCOH Full time

    About the Role:The Quality Assurance Manager will play a pivotal role in driving a culture of excellence within DCOH, contributing to its overall success, reputation, and delivery of high-quality projects safely, on time, and within budget.Key Responsibilities:Develop and implement quality assurance procedures and systems to ensure compliance with regulatory...

  • Digital Quality Assurance Manager

    5 days ago

    Australia AusNet Services Ltd Full time

    Job SummaryAusNet Services Ltd is seeking a highly skilled Digital Quality Assurance Manager to join our Digital PMO Team. As a key member of our team, you will be responsible for monitoring and enhancing the quality of digitally enabled programs and projects within AusNet.Key ResponsibilitiesEnsure Compliance: Actively engage with project stakeholders and...

  • Quality Assurance Manager

    6 days ago

    Australia DCOH Full time

    About the Role:The Quality Assurance Manager will play a pivotal role in driving a culture of excellence within DCOH, contributing to its overall success, reputation, and delivery of high-quality projects safely, on time, and within budget.Key Responsibilities:Develop and implement quality assurance procedures and systems to ensure compliance with regulatory...

  • Quality Assurance Manager

    1 week ago

    Australia mexec Full time

    About MEXECMEXEC is a leading biotechnology company dedicated to delivering innovative solutions for early and accurate breast cancer diagnoses. Our mission is to facilitate early intervention and improve outcomes for women.The OpportunityWe are seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will...

  • Quality Assurance Specialist

    5 days ago

    Australia PR Projects Full time

    Job Title: Quality Assurance Specialist Job Summary: We are seeking an experienced Quality Assurance Specialist to join our team at PR Projects. Key Responsibilities: Quality Assurance Oversight: Develop, implement, and maintain quality assurance programs and processes to ensure compliance with company standards, industry regulations, and best practices....

  • Divisional Quality Assurance Manager

    1 week ago

    Australia Circular Plastics Australia Full time

    About this OpportunityCircular Plastics Australia is seeking a highly skilled Divisional Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for developing and implementing quality strategies and systems to ensure product and process quality standards are met.Your Key ResponsibilitiesDevelop and Implement...

  • Quality Assurance Specialist

    1 week ago

    Australia Advance Immigrations Full time

    Advance Immigrations is seeking a Quality Assurance Specialist to join our team.About the Role:We are looking for a highly skilled Quality Assurance Specialist to join our team at Advance Immigrations. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.Key Responsibilities:Customer Feedback...

  • Quality Assurance Specialist

    1 week ago

    Australia Switch Full time

    We're seeking a talented Quality Assurance Analyst to join our team at Switch, a leading digital transformation and modernisation company based in Sydney. As a Quality Assurance Analyst, you will play a crucial role in ensuring the overall quality of our software solutions.About the RoleThis is a full-time hybrid position that involves performing quality...

  • Quality Assurance Specialist

    6 days ago

    Australia Sharp & Carter Full time

    About Sharp & Carter We are a leading provider of high-quality sterilization services, dedicated to maintaining the highest standards in safety and quality while ensuring compliance with regulatory requirements and industry standards. As a top pharmaceutical company, we prioritize a clean, controlled environment essential for product integrity and superior...

  • Quality Assurance Lead

    1 week ago

    Australia Haleon Full time

    Job DescriptionAbout the Role:We are seeking an experienced and dynamic Quality Assurance Lead to join our team at Haleon. As a key member of our senior leadership team, you will be responsible for developing and implementing our quality assurance programs, ensuring we meet regulatory standards and uphold our high organizational policies.Key...

  • Quality Assurance Specialist

    7 days ago

    Australia Future Generation Joint Venture - FGJV Full time

    About the RoleThe Future Generation Joint Venture (FGJV) is seeking a highly skilled Quality Assurance Specialist to join our team on the Snowy 2.0 project. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in all aspects of the project.Key ResponsibilitiesDevelop and implement quality...

  • Quality Assurance Specialist

    6 hours ago

    Australia DHL Germany Full time

    Quality Assurance Officer RoleAs a Quality Assurance Officer at DHL Germany, you will play a crucial role in ensuring the smooth operation of our warehouse and meeting customer objectives. In a fast-paced environment, you will have the autonomy to make decisions and continually grow professionally.Key Responsibilities:Provide QA support and management for...

  • Quality Assurance Specialist

    1 week ago

    Australia Moec Pty Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Moec Pty Ltd, a leading construction contractor in the Mining and Oil & Gas Industries. As a Quality Assurance Specialist, you will play a critical role in ensuring the highest standards of work quality and compliance with regulatory requirements.Key...

  • Quality Assurance Lead

    5 days ago

    Australia One Impression Full time

    At One Impression, we are seeking a highly skilled and experienced Quality Assurance Lead to join our team. As a key member of our software development team, you will be responsible for ensuring the quality and stability of our software products.Key Responsibilities:Develop and Implement Quality Assurance Plans: Create and implement comprehensive quality...

  • Quality Assurance Manager

    1 week ago

    Australia Alltype Engineering Full time

    Alltype Engineering is a multifaceted engineering company providing fabrication and installation services to the Oil & Gas, Water, Power Generation, Infrastructure, Mining, Resources, Utility, Petrochemical, and Defence industries, in both the private and public sectors.Alltype Engineering has been operating since 1985, and our longevity is a result of the...

  • Quality Assurance Specialist

    1 week ago

    Australia Imagineelc Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Imagine Education Group. As a Quality Assurance Specialist, you will play a critical role in ensuring the highest standards of quality and compliance across our childcare centres.Key ResponsibilitiesConduct regular site visits and inspections to assess program...