Senior Quality Validation Engineer (m/f/d)

REFERENCE NUMBER:

517647/1

MY DUTIES:

- Review, update and implement EU MDR technical documentation for BSI submission
- Provides support in developing and approves operating procedures, manufacturing control plans, pFMEA
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
- Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data
- Demonstrate proficiency in applying various tools and methods (for example, Process Excellence) to identify and realize process and business improvements
- Partners with Supply chain, R and the investigation/correction of process failures when needed
- Ensures that Process Quality control plans are in accordance with product risk level and are consistently followed. Implements and/or maintains production and process controls using appropriate techniques (for example process capability measures, statistical process controls, process performance metrics)
- 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

MY QUALIFICATIONS:

-A minimum bachelor’s degree in Engineering or related technical discipline with profound experience in quality is required. A Master’s or other advanced degree is a plus
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Experience working in both an FDA and European regulatory environment is preferred. Working knowledge of GMPs, QSR, 21 CFR 820, MDD, ISO13485 and ISO14971 is required. MDR is a plus
- Experience working on New Product Introduction process and Process Validation is required
- Fluency in English is required
- Fluency in French is required

MY BENEFITS:

- Dynamic Environment

PROJECT INFORMATION:

- Medical device company

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Manel Kamelia Sendi

Reference number
517647/1

Contact
E-Mail: [email protected]