Team Lead (Quality) – Medical Device

Recruiter
Morgan McKinley
Employment Type
Permanent
Salary
Not disclosed
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One of the world leaders in life changing medical solutions are looking for a Quality Team Lead to join their expanding business operations at their Cork site. If you have 4+ years’ experience in a regulated manufacturing facility (i.e. pharma, medical device or electronics) and enjoy supporting, leading and developing a team around you then this could be the role for you.

This is a fast paced, dynamic environment so this role is most suited to someone who likes to work on their own initiative and is proactive. This company invests a lot in their people and will receive excellent exposure to business leads in this role.

The main focus of this role is to provide QA support to Operations and supporting process implementation from a QA standpoint.

The role in more detail;

  • Supervision of Quality Technicians and Quality Engineers
  • Drive and implement process improvements (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
  • Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
  • Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
  • Drive and implement plant wide quality system improvements.
  • Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
  • Approval of change requests for product, process and quality system changes.
  • Customer complaints: Approval of analysis reports and analysis of complaint trends.
  • 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).
  • MRB: Review of MRB trends and identification of appropriate corrective actions when required.
  • Perform internal quality audits.
  • Support the implementation of Lean Manufacturing across the site.
  • Transfer and implement product and processes from development or from another manufacturing facility.
  • Monitoring of key quality metrics in areas of responsibility to identify improvement opportunities.

Education/Experience:

  • Requires a minimum level 8 qualification in a relevant Engineering / Science degree.
  • Excellent interpersonal and communication skills.
  • Ability to work as part of a team and meet targets/goals efficiently.
  • Excellent analytical and problem-solving skills.
  • Demonstrated decision making skills.
  • Minimum of 4+ years’ experience within a manufacturing environment.
  • People management experience is advantageous.
  • Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.

If you are interested in this opportunity, or if you would like to find out more, reach out to Kellie O’Donovan today on or

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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