Our client, a medical device company in Cork are currently looking to recruit a Quality Engineer for their site.
- The Quality Engineer conducts assignments encompassing complete projects or portions of major projects. They determine methods and techniques to be used or adapt standard methods to meet variations. They coordinate phases of work internally and externally.
- The Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Conduct benchmarking to develop more effective methods for improving quality
- Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
- Review/analyse whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
- 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.
- Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
- Supports new product introduction as part of design transfer.
- 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.
- Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
- Analyse/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
- Approve IQ, OQ, PQ, TMV or Software Validation
- Partners with company Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
- Develop, interpret and implement standard and non-standard sampling plans
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
- Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
- Document, justify, review or analyse whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
Other Skills, Experience and Education
- 5 yrs. experience in a regulated environment.
- SIX SIGMA – Certification
- Experience in performing Design of Experiments (DOE) and leading Failure Mode Effects Analysis (FMEA)
- Experience of the design and qualification documentation standards to current FDA expectations
- Knowledge of statistical packages and Microsoft Office systems required.
- Proven ability to review and critique Quality Critical technical documents.
- A good understanding and working knowledge of FDA and ISO regulations.
- Knowledge of lean manufacturing
- Five years’ experience as Quality Engineer working in a cGMP environment preferably in medical device.
- Positive attitude
- Continuous Improvement orientation
- Accepting of change
- Flexible - Calmly reacts to the unexpected
- Credible – Accountable for decisions
- Self-Motivated – requires minimal direct supervision.
- Results focused – maximizes business benefit from all activities.
- Innovation – thinks laterally but within a compliant framework.
- Organized – Able to cope with extensive documentation and planning requirements.
- Six Sigma or quality engineer certified,
- Structured problem solving and decision making skills working in a team environment.
- Ability to participate in or leading cross functional project teams
- Must have good written and presentation skills and be able to communicate effectively throughout organization
- Demonstrated Experience working with data base applications desired
- Ability to set priorities while ensuring compliance is not compromised.
- Experience in performing Design of Experiments (DOE) and leading
For further information on this Quality Engineer role in Cork please contact Niamh Hlubek on 0868168298 / email@example.com
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