Continuous Improvement Specialist

1 week ago


Australia beBeeEngineering Full time $114,000 - $115,000
Quality and Continuous Improvement Engineer

We are seeking an experienced Quality and Continuous Improvement professional to improve product quality and manufacturing processes, initiate and coordinate continual improvement programs, and conduct process improvement analysis.

Key responsibilities include:

  • Improving product quality and manufacturing processes
  • Initiating and coordinating continual improvement programs
  • Conducting process improvement analysis, pFMEA, dFMEA, DoE, CpK, PpK, Gage R&R analysis etc.
  • Providing recommendations for process improvement, and providing necessary trainings
  • Reviewing customer/supplier quality agreements, policies, and procedures and providing necessary technical guidance to develop the management system
  • Creating documentation of standards, procedures, work instructions, manuals, etc.
  • Performing the role of Management Representative (MR) and developing the Medical Devices Quality Management System (ISO-13485:2016)
  • Conducting supplier quality audits, internal audits, and third-party audits
  • Executing problem-solving, investigating customer complaints, and manufacturing problems by providing 8D reports
  • Driving corrective and preventive actions (CAPA) to eliminate recurrent process failures
Required Skills and Qualifications:
  • Tertiary qualifications in Science, Engineering, Biotechnology, Biological Sciences, or equivalent qualifications
  • At least 3 years of experience in a quality function in the Medical Devices Industry
  • ISO 13485 Lead auditor certification, Six Sigma Green Belt certification, or Lean manufacturing certifications
  • Strong knowledge and experience in GMP, FDA-21CRF, TGA, and MDSAP regulatory requirements
Benefits:
  • Opportunity to work with a dynamic team
  • Chance to improve product quality and manufacturing processes
  • Professional growth and development


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