your search starts here

Apply for this job

























If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box



If you are having difficulty you can always email your cv to applications@lifescience.ie

Senior Quality Engineer

Reference:SMC035641
Location: Cork
Qualification:Degree
Experience:See description
Job Type:Fixed Term Contract
Salary:Not Disclosed
apply for job
May be suitable for: Senior Quality Engineer

Summary

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.

Duties

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
• Conduct benchmarking to develop more effective methods for improving quality
• Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
• Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
• Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
• Supports new product introduction as part of design transfer.
• Lead and maintain Material Review Board.
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
• Approve IQ, OQ, PQ, TMV or Software Validation

Experience & Education
• A minimum of a Bachelors Degree, preferably in Engineering or related technical field.
• Experience working in both an FDA and European regulatory environment is preferred.
• This position will require relevant experience working in manufacturing/operations.



If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480



Apply


contact info


search


job tools

login to your account

forgot your password? click here