Position Overview
The Senior Quality Engineer plans, conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field. They apply comprehensive and diverse knowledge of engineering principles and practices withinbroad assignment areas. They may coordinate and direct activities of technical support staff and are responsible for technical development of assigned staff.
Major Responsibilities & Duties:
- 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.
- Conduct benchmarking to develop more effective methods for improving quality supports the development of quality engineering and quality compliance with theright skill sets for new product introductions, and product life cycle management.
- Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
- Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
Qualifications
- A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 4-6 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.
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
