Senior Quality Engineer

Senior Quality Engineer

Provides leadership and support to root cause investigation activities and ensures good Quality Engineering practices are used in investigations. Drives continuous improvement through data driven approaches and monitoring of quality systems.

Responsibilities:

• Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes
• Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including GMP, EES, and ISO.
• Addresses and corrects product and process complaints.
• Reports on contract manufacturer performance metrics and ensures management reviews.
• Oversees audits of all quality system categories to assess compliance to process excellence standards.
• Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management
• Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
• Responsible for supporting the activities of Operations/Engineering/information management in building quality into our products.
• Leads and executes upgrades to Quality System
• Support QA programs in assuring compliance to the pertinent regulation
• Identify and lead cost and technical improvements under the departments' continuous improvement program.
• Provide key inputs and leadership into transformational process developments.
• Project Management - provide timely and accurate reporting on project activities.
• Lead or actively participate in cross-functional teams to ensure New Product Introduction/Research and Development projects are completed in a timely manner.
• Ensure effective closure on Quality System documents (Audit Actions, NCR's, CAPA's, Maps, etc).
• Ensure all process developments, NPI etc are managed in accordance with the Quality management system.
• Implementation of safety/environmental requirements on purchase of all new equipment.
• Work with team leader to develop and implement strategic engineering Goals & Objectives.

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Qualification:

• Degree Qualified with Science or Engineering Degree with 3-5 years relevant experience.
• Excellent working knowledge of process excellence / QE tools such as pFMEA, SE, statistical analysis, SPC
• Excellent IT skills e.g., experience in minitab, Excel reports
• CAPA and RCI experience
• Risk management experience
• Automated process controls experience

Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-group.com.

If you would like to discuss this vacancy further or to discuss your career options in confidence, please email Fred Chesne fchesne@berkley-group.com 085 178 6539 with any questions and you're up to date CV.