Position Overview
This individual will be working with Quality Assurance colleagues to ensure that product is made to a high standard and is extremely compliant to relevant regulations within the manufacturing area. They will utilise Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. This individual will also utilise Quality Engineering principles and problem-solving skills to improve and maintain products/processes.
Major Responsibilities & Duties:
- Support quality improvement initiatives such as process and product characterisations that lead to continuous / cost improvements.
- Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
- Conduct periodic line audits to assess for production controls such as lot segregation.
- Review results of area audits to ensure that corrective and preventive actions are adequate.
- Supports new product introduction as part of design transfer. Product Quality, Control & Disposition and Performance Standards
- Supports activities related to the Material Review Board.
- Conduct investigation, bounding, documentation, review and approval of non conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Approve IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
Qualifications
- A minimum of a Bachelor's Degree, preferably in Engineering or related technical field.
- 2+ years manufacturing experience, ideally within a Quality Assurance capacity and within a highly regulated manufacturing environment.
- Good knowledge of product/process Risk Management (FDA and ISO standards).
- Experience with implementing appropriate risk mitigation.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred.
- The ability to perform "hands on" troubleshooting and problem solving.
- Good technical understanding of manufacturing equipment and processes is required.
If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on 021 2300 300.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
