Senior Quality Systems Specialist

1 week ago

Sydney, New South Wales, Australia beBeeQuality Full time $120,000 - $170,000
Quality Assurance Role

The primary objective of the Quality Assurance function is to ensure that management systems are established to enable business compliance, multiple regulatory frameworks and to support the design, development and manufacture of products which meet customer quality requirements.

  • Create and build relationships with medical device regulatory teams in every country to ensure timely registration and meet business needs.
  • Responsible for all aspects of auditing to ensure regulation compliance, quality best practice, process improvements and development of supplier quality systems.
  • Provides broad business technical support around QA systems and processes to the organization.
  • Leads and implements significant quality projects across the business and creates and improves quality and business processes.

Key Responsibilities:

  • Support the factory focus teams to achieve current KPI of quality, delivery and cost.
  • Lead and support new product introduction process into manufacturing with active involvement in appropriate XFT deliverables and phase transitions in collaboration with QA counterpart in XFT and QA/RA team.
  • Proactively improve quality systems to support manufacturing including reviews across all areas of manufacturing and QA production support team to ensure a level of consistency and standardization in ResMed QMS across various manufacturing business units and sites.
  • Ensure risk of non-compliance and related business risks are mitigated.
  • Provide quality/technical leadership through mentoring/coaching.
  • Ensure compliance to ResMed QMS; strong knowledge, application of and compliance to FDA Quality System Regulations, GMP, and applicable ISO/regulatory standards.
  • Ability to work collaboratively across various QA functions in ResMed (quality systems & audit, design, supplier, manufacturing, and customer quality).

Requirements:

  • Bachelor's degree in engineering or science with 5 years' experience in a regulated volume manufacturing industry.
  • Experience in quality systems/mfg quality, risk management, requirements management and process validation.
  • Self-starter, with the ability to work with minimal supervision and with a sense of urgency.
  • Good planning and organizational skills; ability to take own initiative and ownership.
  • Strong inter-personal, communication, and negotiation skills with the ability to interact positively with senior management and manage stakeholders.

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