Quality Engineer in Raron
Quality Engineer - Raron
Jocelyn Blackham is recruiting for a Quality Engineer to join a company in the Medical Device industry at their site based in Raron on a contract basis, until the end of October 2019, with the possibility extension.
The main purpose of the role will be to:
- Take a lead role in creating and releasing inspections plans, determining methods and techniques to be used or adapt standard methods to meet variations.
- Coordinate phases of work internally and externally.- Utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.
- Utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.
- Support quality improvement initiatives such as process and product characterizations that lead to continuous/cost improvements.
- Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
Further responsibilities will include:
- Conducting investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Documenting, justifying, reviewing or analyzing whether proposed changes to a process will not enhance the risk level or whether change will result in potential non-compliance to a required standard such as the QSRs.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- A minimum of a Bachelor's Degree, preferably in Engineering or related technical field.
- Experience working in both an FDA and European regulatory environment is preferred.
- Relevant experience working in manufacturing/operations.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
- Demonstrated project management and project leadership abilities are preferred.
- Must be fluent in English and German (spoken and written).
This is an excellent opportunity to join a global Medical Device company.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email jblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference 45336 in all correspondence.
