Senior Quality Engineer

This job has now expired please search on the home page to find live IT Jobs.

Reporting to the Quality Engineering Manager, the Senior Quality Engineer plans, conducts and provides direction on all quality engineering activities. They apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas. They may coordinate and direct activities of quality engineers and other quality engineering staff. They are responsible for development of assigned staff.

The Key Duties and Responsibilities include:

1 Direct supervision of Quality Engineers including all recruitment, performance reviews and career development.

2 Utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision while ensuring production build schedule attainment.

3 Lead and manage investigations providing formal structured approach to identify root causes, establish corrective actions and execute prevention plans in products and/or processes.

4 Employ appropriate risk management to prevent unanticipated failure modes and improve capability of processes.

5 Ensures effective quality strategies are created for the validation of equipment, test methods and processes as well as master validation plans and risk management documentation in accordance with regulatory requirements and internal Company requirements.

6 Utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.

7 Reviews Analytical Methods and Specifications, Validation Protocols, Deviations, Investigations, Impact Assessments and other forms of Quality documentation as assigned.

8 Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.

9 Perform an active role in further development of the quality management system and drive continuous improvement and innovation from a quality perspective.

10 Actively participate in external audits by Notified Bodies and Health Authorities as subject matter expert for areas of responsibility and guide audit preparation activities within the Quality Engineering group.

Candidates should have:

* Knowledge of FDA, medical device, GMP and validation requirements.

* Experience in Equipment and process validations.

* Knowledge of Statistics

* Skills: Project management, problem solving, statistical analysis and word processing.

* People management experience.

* Report writing expertise and highly developed people skills.

Education

Minimum: Bachelor's degree from an accredited institution in a technical discipline.

Preferred: Master's degree in a technical discipline

Alternative combination: Further qualifications such as Associates Degree/Diploma/Masters in Technical/Physical Sciences/Statistics for reduced experience will be considered.

Experience

Minimum: 10+ years' technical & validation experience.

Preferred: 15 years' Q.A. & technical experience in the medical device, pharmaceutical or soft contact lens industry including validation and leadership experience.

Sthree UK is acting as an Employment Agency in relation to this vacancy.