Description:
Global Medical Device company - looking for Quality Operations Engineer. The successful candidate will be responsible for support quality improvement initiatives such as process and product characterisations that lead to continuous / cost improvements.
The Job:
- Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Conduct bench-marking to develop more effective methods for improving quality.
- Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
- Review/analyse whether current product and processes (including actions or decisions conducted) comply to standards such as the QSRs, ISO 13485, etc.
- 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.
- Approve IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans.
Have You:
- A minimum of a Bachelor's Degree, preferably in Engineering or related technical field. Generally, requires 2-4 years related experience.
- Experience working in both an FDA and European regulatory environment is preferred.
- This position will require relevant experience working in manufacturing/operations.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Experience with a proven track record of implementing appropriate risk mitigation.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.