Do you have experience working in a regulated environment? We are partnering with a leading medical device manufacturer, who is looking to hire Quality Team Lead for their facility in Cork. As Quality Team Lead, you will supervise Quality Technicians, provide Quality Assurance Support to Operations, and implement process improvements across all product lines.
Overview of Main Responsibilities ( full job description available on request):
- Ensure Regulatory compliance in the area of responsibility to cGMP’s of all medical device regulatory agencies.
- Approval of change requests for product, process and quality system changes.
- Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
- Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
- Compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements).
- Perform internal quality audits.
- Transfer and implement product and processes from development or from another manufacturing facility.
What the ideal Quality Team Lead looks like:
- Requires a minimum level 8 qualification in a relevant Engineering / Science degree.
- Has experience within Manufacturing Environment.
- Excellent interpersonal and communication skills.
- Ability to work as part of a team and meet targets/goals efficiently.
- Excellent analytical and problem-solving skills.
- People management experience is advantageous.
For a confidential discussion and more information on the role, please contact Alicja Burchardt.