Requisition Number: n/a
Country: the Netherlands
The Line Engineer's foremost responsibility is increasing commercial production process robustness and reliability. The line Engineer advises the production department on technical improvements to process equipment through setting up data management systems and subsequent data analysis. Furthermore, the line Engineer supports the production department in implementing these solutions. To achieve these, the Line Engineer teams up with the Production Support and Engineering, and Quality. In case of production or quality issues, the Line Engineer supports the operations team by performing root caude investigations and driving the closure of NCRs, CAPA's and other quality documents.
Qualifications - Education & Experience
Key responsibi;ities fot the Line Engineer are:
- Initiate and execute the improvement of dedecated production processes (assembly, packaging, inspection, etc.) to ensure production targets will be met
- Support/trouble shooting in case of production problems
- Lead technical/process related customer complaints, deviation management and corrective and preventive action (CAPA) plans. Lead root cause analyses.
- Manage changes through Change Forms and implement quality documents to support these changes (e.g. Work Instructions)
- Initiate and drive quality improvements through technical solutions
- Provide technical leadership on all aspects of engineered improvements
- Specify suitable process equipment for medical device manufacturing (e.g. Process equipment, assembly machines, test equipmet and utilities)
- Improve and (re-)validate (automation) processes. This includes writing; User Requirements Specifications ( URS) Equipment design FAT / SAT / DOE / IQ / OQ / PQ documents
- Analyses and improve (preventive) maintanance plans, spare parts management programs and systems to ensure process reliability Initiatate, run, validate and upgrate processes/equipment and test equipment
Knowledge, Skills and Experience:
- Polytechnic Bachalor degree (BSC) e.g. Mechanical / Chemical engineering, Mechatronics, Industrial Automation with proven track record with at least 3 years of engineering experience.
- Experience with process and equipment design and development (for medical devices)
- Practical experience with equipment and process life cycle management through commissioning. IQ, OQ , PQ and decommissioning (preferably in a medical device or pharmaceutical company)
- Experience with GMP )e.g. ISO 13485) in an production environment
- Mechatronic High level knowledge (PLC, control systems etc.)
- Basic knowledge of Statistical Techniques.
- Practical experience in lean and six sigma implementation (green belt and black belt are a plus).
- Pro-active and problem solving.
- Project management and team working.
Qualifications - Skills & Competencies
Are you interested in this position and based in The Netherlands? Please send your CV and application to Heleen Stork, Corporate Recruiter EU. E-mail: email@example.com