Full Time Quality and Continuous Improvement Engineer - Ballarat

Requirements:
Position Title: Full- Time Quality and Continuous Improvement Engineer
Salary: A$ 115,000 + Superannuation
Our client is an Australian- Ased, globally- Oriented Life Sciences business, focused on the advancement of biomedical cryopreservation.
This dynamic, cutting- Edge business is currently experiencing an exciting period of growth and development and is looking for an experienced Quality and Continuous Improvement Engineer to join its close- Knit Ballarat operation.
Task included:
- Improve product quality and manufacturing processes
- Initiate and coordinate continual improvement programs
- Conduct process improvement analysis, pFMEA, dFMEA, DoE, CpK, PpK, Gage- R&R analysis etc.
- Provide recommendations for process improvement, and provide the necessary trainings
- Review customer/ supplier quality agreements, policies, and procedures and provide necessary technical guidance to develop the management system
- Create documentation of standards, procedures, work instructions, manuals, etc.
- Perform the role of Management Representative (MR) and develop the Medical Devices Quality Management System (ISO- 13485: 2016)
- Conduct supplier quality audits, internal audits, and third- Arty audits
- Execute problem- Olving, investigate customer complaints, and manufacturing problems by providing 8D reports
- Drive corrective and preventive actions (CAPA) to eliminate recurrent process failures
Skill level required:
- Tertiary Qualifications in Science, Engineering, Biotechnology, Biological Sciences, or equivalent qualifications
- 3+ years experience in a quality function in the Medical Devices Industry
- ISO 13485 Lead auditor certification is preferred
- Six Sigma Green Belt certification or Lean manufacturing certifications are preferred
- Strong knowledge and experience in GMP, FDA- 21CRF, TGA, and MDSAP regulatory requirements
- Proven experience in design control and the creation of medical device technical documentation
- Proficiency with software and systems of MATLAB, Minitab, SAP MRP(Q- 1, Q- 2, Q- 3, F1), Qualio e- QMS, FactoryLogix MES, Auto CAD, Salesforce, Microsoft Powerpoint, Access, Word, Excel, and Outlook
Responsibilities:
Task included:
- Improve product quality and manufacturing processes
- Initiate and coordinate continual improvement programs
- Conduct process improvement analysis, pFMEA, dFMEA, DoE, CpK, PpK, Gage- R&R analysis etc.
- Provide recommendations for process improvement, and provide the necessary trainings
- Review customer/ supplier quality agreements, policies, and procedures and provide necessary technical guidance to develop the management system
- Create documentation of standards, procedures, work instructions, manuals, etc.
- Perform the role of Management Representative (MR) and develop the Medical Devices Quality Management System (ISO- 13485: 2016)
- Conduct supplier quality audits, internal audits, and third- Arty audits
- Execute problem- Olving, investigate customer complaints, and manufacturing problems by providing 8D reports
- Drive corrective and preventive actions (CAPA) to eliminate recurrent process failures

Benefits:
Salary: A$ 115,000 + Superannuation

JOB TYPE
Work Day: Full Time
Employment type: Permanent Job
Salary: AUD 114,000.00 - 115,000.00 Yearly
Positions available: 1


JOB REQUIREMENTS
Minimal experience: Unspecified
Gender: Indistinct