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The primary function of this role is to provide technical leadership within Quality Engineering to help provide support to Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and Development and Engineering Sustaining teams. This includes but is not limited to, providing support to process validation, change requests, non-conforming product issues, Cook Medical Corrective and Preventive Action program, Design and Process FMEA, risk assessment and associated Quality System Documentation.
Reporting to: Team Lead, Quality Engineering
Department: Quality Engineering
Find out more about Cook Medical here
Responsibilities
* Department: Quality Engineering
* Drive all assigned Quality Engineering projects and ensuring that they are managed in a structured fashion and completed in compliance with the relevant procedures.
* Manage and drive project activities to ensure timely completion of project milestones.
* Represent team at key review meetings.
* Work closely to build effective relationships with other functions in particular Operations, IT, Engineering and Regulatory teams.
* Lead in the area of FDA, QSR and ISO13485 requirements, promoting, awareness of best industry practice and making appropriate decisions on a daily basis using the Quality Engineering Manager as the final arbitrator on critical quality decisions.
* Identify and implement opportunities for improvement and implements under their own initiative.
* Maintain a proactive approach to developing Cook’s Quality system to meet the changing needs of the business.
* Ensure that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
* Demonstrated proven experience and proficiency across functional areas: *Essential
* o Design*
* o Process*
* o Risk Management*
* o Software Validation.
* o Supplier Quality.
* o CAPA.
* o Non conformances.
* o Customer Complaints
* o Sterilisation
* o Statistics
* o Facilities/ Environment
* o Microbiology/ Biocompatability
* o 6 Sigma/ Lean/ Continuous Improvement
* Support of the Internal Audit, Supplier Audit and Regulatory Audit Programmes.
* Prepare, execute and analyse Quality Engineering Documentation.
* Trending and analysis of key Quality metrics.
* Responsible for the assessment of risk throughout Quality Engineering key processes and systems.
* Provide mentoring to team members to ensure the effective completion of activities associated with their role.
* Assist with Quality Engineering Team Lead\Quality Engineering Manager to ensure the appropriate allocation of resources and prioritisation of efforts.
* Delegate for the Quality Engineering Team Lead\ Quality Engineering Manager.
* Ensure that Cook’s Code of Conduct is considered with in all business matters carried out on Cook’s behalf.
Qualifications
* Department: Quality Engineering
* Third level qualification in Science, Engineering or relevant technical discipline.
* Proven knowledge and experience (minimum 4 years at QE level) of working with ISO13485, ISO14971, EU Medical Device Regulation 2017/745 and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
* Excellent communication and inter-personal skills.
* Proven track record of perusing continuous self-improvement.
* Good working knowledge of Microsoft Office.
* Proven Problem-Solving Skills.
* Taken lead in technical negotiations. Influence others in problem solving/ issue resolution.
* Good working knowledge of statistics.
* Knowledge and experience of all aspects of validation.
* Excellent organisational, time management and presentation skills.
* Excellent attention to detail.
* Proven self-starter
* Willingness and availability to travel on company business.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Temporary
Job function
* Job function
Quality Assurance
* Industries
Medical Equipment Manufacturing
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