Engineering & Electronics
Senior Quality Engineer
PE Global is currently recruiting for a Senior Quality Engineer on behalf of our client based in Limerick. This is an initial 11 month contract role.
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.
- 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 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, presenting reports to management
- Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
- 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 and efficient 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.
- Work with team leader to develop and implement strategic engineering Goals & Objectives.
- Support the implementation of all engineering and plant strategic initiatives.
- Maintains and develops risk management lifecycle.
- Ensuring continuous improvement and understanding of measurement systems used on-site, driving down variance in test methodology.
- Develops site knowledge on manufacturing process knowledge, and monitors inputs and outputs to the processes, and implements and drives corrective actions.
- Sustains and advocates Credo based standards in all aspects of work.
Education and Experience:
- Degree Qualified with science or Engineering Degree with 3-5 years relevant experience in Medical Devices/ Pharmaceutical Industry
- Excellent working knowledge of process excellence / QE tools such as pFMEA , SE , statistical analysis , SPC
- Excellent IT skill eg , experience in MiniTab , excel reports
- CAPA and RCI experience
- Risk management experience
- Automated process controls experience
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***