Lead Quality Engineer

This is an exciting opportunity for a Lead Quality Engineer  to join a leading global medical device company based in  Cork .

Roles/Responsibilities

As a Lead Quality Engineer, you will:

• Identify and resolve complex exceptions to work assignments.
• Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process-related findings.
• Read and interpret technical drawings, procedures, and protocols
• Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in the identification of primary root causes, and understanding corrective and preventative actions. 
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of the non-conforming product.
• Participates in Customer Complaints investigation for areas under their control.
• Document investigation findings in the analysis report on GCS2
• Become a trainer for the Software related to the complaints handling process (GCS2), as required.
• Continually seeks to drive improvements in product and process quality.
• Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decisions on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions
• Knowledgeable on Risk Management, BSEN 14971 requirements.
• Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
• Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanliness).
• Gives technical guidance to Associate Quality Engineer, Technician, and Inspection staff.

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.
• Minimum of 3+ 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.

For a confidential discussion and more information on the role, please contact Kevin Griffin

Kevin Griffin