CK Group are recruiting for a dynamic candidate to join an innovative Medical Device company at their site based in Neuchatel on a contract basis (6 or 12 month contracts available).
The main purpose of the role will be to:
- Review, update andimplement EU MDR technical documentation for BSI submission
- Provide support in developing and approve operating procedures, manufacturing control plans, pFMEA
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests,measurement system analysis
- Have 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.
Further responsibilities will include:
- Partners with company's Global Supply chain, R&D, RA and material suppliers to ensure appropriate application of process validation, process control, and risk management; 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 usingappropriate 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.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- A minimum bachelor's degree in Engineeringor related technical discipline with a previous 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 require
- Ability to “think out of the box”, flexibility, open-minded, team spirit and “can do” attitude are required personal skills. Good technical understanding of manufacturing equipment and processes is required
- Proven evidences of multi-tasking and proven evidences of taking ownership of action outside of its direct field of responsibilities are required
- Excellent problem solving, decision-making, and root cause analysis skills are required
- Fluency in English is required
- Fluency in French is required
For more information or to apply for this position, please contact Adrien on 0041 (0) 78 250 85 35 or email firstname.lastname@example.org. Please could you send any correspondence in English. Please quote reference 00049555 in all correspondence.