Senior QE

Senior Quality Engineer

The 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.

· Applies multifaceted industry and process excellence standards on an experienced level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (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, communicating 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 and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness.

· Leads and implements 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.

· New Product Introductions & Product Transfers.

· Lead or actively participate in multi-functional teams to ensure New Product Introduction/Research and Development projects are completed in a timely and efficient manner.

· Actively collaborating with multi-functional team members, always practicing good teamwork in support of day-to-day operating requirements.

· Demonstrate strong leadership and a clear identifiable work ethos within the team.

· Ensure effective closure on Quality System documents (Audit Actions, NCR’s, CAPA’s, Maps, etc).

· Ensure all process developments, NPI etc are led 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.

· Maintains and develops risk management lifecycle.

Qualification:

• Level 8 Degree Qualification in Science or Engineering with 3-5 years relevant experience.
• Excellent working knowledge of process excellence / QE tools such as pFMEA, SE, statistical analysis, SPC.
• Excellent IT skill e.g., experience in Minitab, excel reports.
• CAPA and RCI experience.
• Risk management experience.
• Automated process controls experience.
• Good presentation skills

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 0851786539 with any questions and your up-to-date CV.

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