Job Details
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| Senior Quality Engineer | | |
| Location: | | Europe (Non UK) | | |
Description
Our client now has an opening for a Senior/Principal Quality Engineer in their Pre and Post Production department. This is a key position within the Quality Organization providing Leadership in Quality Assurance supporting all Post Production Operations for the site, (product release, shipping, sterilization, warehouse controls).
Key Responsibilities:
· Provides leadership for activities related to bulk packaging, sampling, distribution, sterilization, and product release to meet their area’s objectives of quality, cost and output.
· Demonstrates a thorough understanding of quality standards, including MDD, ISO13485, 21CFR 820, 21CFR 210/211.
· Contributes to the development, maintenance and improvements of post production policies and procedures.
· Provides guidance to other functional areas in applying product release and distribution quality system requirements.
· Identifies and resolves exceptions to work practices. Works with product line engineering to assess and address material quality issues as a result of issues occurring post production.
· Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
· Contributes to and participates in Non-conforming Review Boards.
· Acts as a leader of quality within the area constantly promoting awareness of best industry practices.
· Assists in establishing and implementing Post Production Department improvement projects and goals.
· Participation in and leadership of CAPA teams.
· Subject matter expert for the area during external audits.
· Approval of change requests for product, process and quality system changes.
· Monitoring of key quality metrics in areas of responsibility to identify improvement opportunities and as input to Management review.
· Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects
Skills, Experience & Qualifications:
· Bachelor’s Degree in Engineering, Science or Quality Assurance.
· At minimum 4 years experience in an Engineering / Quality role in a pharmaceutical/medical device environment with direct experience in a GMP regulated environment a distinct advantage.
· Experience in FDA or notified body audits essential.
· Strong team member with the ability to identify and drive quality improvements.
· Ability to work with minimum supervision.
· Excellent interpersonal and communication skills
CCP Can Offer You
CV advice | interview coaching | Tips & advice | CV advice | salary & benefits advice | career counseling | Career Direction - (full range of psychometric tools available) / Psychometric Testing Services /Occupational Personality Assessments (SHL Partner)
For further information please contact Joe Dervan at CCP Recruitment on 091 730022 or email joe@ccprecruit.ie
Recruitment Specialists in Science, Pharmaceutical & Food
Science Jobs / Pharmaceutical Jobs / Food Jobs / Scientists / Science in the West of Ireland / Pharmaceutical jobs Galway / Pharmaceutical jobs Mayo / Science Jobs Sligo /
Science positions Clare / Laboratory jobs in West of Ireland / Food Science jobs Galway / Food Science jobs west of Ireland / Food Technologists
We are interested in hearing from:
Analyst Chemistry /Analytical chemist / Animal laboratory technician / Biochemist / Biochemist, clinical / Biochemistry Technologist/Biomedical engineer / Biomedical Equipment Te | | |
Reference
IJ-JD/41420/IJP | | |
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