Senior Quality Assurance Specialist

1 week ago

Adelaide, South Australia beBeeQuality Full time $120,000 - $140,000
Job Description

We are seeking an experienced professional to lead the implementation of quality assurance practices, process controls, and Corrective and Preventive Action activities.

This role involves:

  • Building a culture committed to quality, ensuring accordance with applicable regulatory requirements, internal quality standards, and customer needs.
  • Leading the implementation of quality assurance practices, process controls, and Corrective and Preventive Action activities.
  • Performing and maintaining product/process risk analysis (FMEA, DFMEA, PFMEA), and supporting the investigation of nonconformance, audit findings, CAPA's, complaints, and SCAR's by conducting CAPA investigations, root cause analysis and effectivity checks.
  • Reviewing and managing customer quality and regulatory requirements.
  • Reviewing supplier manufacturing processes and collaborating with them on process improvement opportunities.
  • Approving investigations, deviations, change controls, validation protocols, validation reports, Operations SOP's, and in-process controls.
  • Supporting vigilance activities, including implementing and monitoring recalls and field actions.
Required Skills and Qualifications

To be successful in this role, you will bring:

  • A Bachelor's degree in Science or Engineering or related field or 7+ years of related experience in lieu of degree.
  • 4+ years quality engineering experience within a manufacturing environment.
  • Experience leading a team with broad skills and functional requirements.
  • Solid understanding of global regulatory and quality requirements associated with electromechanical devices such as CE, GOST, ROHS would be beneficial.
  • Lead Auditor certification would be ideal.
Benefits

In return, we offer:

  • A competitive salary and performance-related bonus structure.
  • Recognition and awards program for individual and team performance or for taking an active approach to help our colleagues, culture, and customers.
  • Opportunities as a team member of a rapidly growing global organisation including access to training and development through our Global University centre.

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