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Sean McCarthy
Life Science

[email protected]
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Quality Engineering Leader - Validation & Change Control

Reference:SMC57695 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Engineering Manager

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


• Process owner for the Validation and Change Control processes.
• Ensure current processes are in compliance to applicable standards and regulations.
• Connect & build relationships across departments with functional leaders and other sites to understand existing expertise as well as opportunities to leverage skills and best practices.
• Engage with broader industry networks and forums on Validation & Change Control topics.
• Lead the QA Validation team in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with Process Changes, Product Transfers and/or New Product Introductions.
• Support the QA Validation team in developing and standardizing guidance for introduction and qualification of processes and equipment to the site.
• Ensure current processes are in compliance to applicable standards and regulations.
Project & Strategy Management
• Create an environment where opportunities for continuous improvement within the Validation & Change Control processes are identified, assessed and tracked to implementation.
• Provide support for Product Transfers and New Product Introductions. Ensure the appropriate Process Validation and Change Control expertise is deployed to successfully implement such projects in line with quality, timeline and cost commitments.
• Develop and implement a strategy for the Validation & Change Control group that aligns with the broader functional and site level strategic goals and priorities.
Quality Engineering & Technical Leadership
• Support and/or lead technical investigation into quality and compliance issues as required.
• Support and/or lead Problem Solving initiatives for medium to high complexity problems where scope may extend across the site.
• Member of the site Quality Leadership Team in managing Third Party / External Quality System audits or inspections.
• Support, lead and / or provide technical oversight and approval for Non-Conformance Investigations & CAPA.

The Quality Engineering Leader – Validation & Change Control is responsible for the following positions who are direct reports:
• QA Validation Engineer
• QA CSV Engineer
• Senior QA Validation Engineer
• Senior QA CSV Engineer
• Staff QA CSV Engineer
• Staff QA Validation Engineer

Experience & Education

• Experience of Process Validation in the Medical Devices industry is required.
• Demonstrated ability to successfully use, and coach others in the use of, recognized data analysis and problem-solving methodologies is required (e.g. DMAIC, Six Sigma, etc.).
• Strong coaching, mentoring and team development skills are required.
• Strong knowledge of Validation and Change Control Processes within the Medical Device Industry is required (including practical experience gained working in these processes).
• Technical training and experience in using Statistical Techniques, Lean and/or Six Sigma methodologies is preferred (e.g. SPC, DOE, Reliability Analysis, etc.).

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.