Quality Engineer

ROLE - Contract Quality Engineer, reporting to Quality Manager is responsible for effectively researching quality issues associated with production problems to determine and eliminate root and causes and diminish occurrences.

Responsibilities will include:
o Managing Customer Quality Plan
o Leading Compliance of Assembly Build Instructions to SOP, Work Instructions
o Supporting Customer Team and leading Customer Quality Contact
o Leading product specific regulatory compliance
o Supporting Technical Training (SFT / External)
o Supporting Supplier Quality, Lead NCM and Customer CAR Process
o Managing Quality Metrics
o Leading the report of customer and factory month metrics, lead Failure Analysis and Customer / Site Audits
o Supporting Quality System / MES and the identification of manufacturing and quality issues effecting product quality
o Leading FMEA, DOE and control plans to prevent product defects. Lead statistical problem solving projects and the definition of problems using statistical tools.
o Lead the analysis and interpretation of various data trends and patterns of other indications of process or system problems.
o Lead the identification of the elements of a corrective-action plan addressing the systemic problem.
o Lead the assessment of the effectiveness of corrective action plans though statistical tools and institute appropriate follow-up actions.
o Support product containment for discrepant material. Support the development of Quality resources and the training of Quality initiatives
o Support the development of report generation tools

PERSON SPEC

- Strong experience of working in a Quality Engineering role in high tech product manufacturing.
- Experience of effectively researching quality issues within a production environment, assessing risks and analysing causes to determine a solution and reduce occurrences.
- Solid knowledge and understanding of ISO 9001 ideally with experience in medical (FDA) or ISO 13485 quality standards.
- Ability to integrate and work positively within the team environment and build and maintain solid working relationships with suppliers and internal customers.
- Excellent communication skills, excellent negotiation and persuasion skills and confident in dealing with people at all levels.
- Experience of working in a low volume production of high tech complex products.
- Highly analytical, with evidence of strong judgement and fast decision making.
- Highly organised, self motivated, with ability to work using own initiative and to strict timescales.
- Personality - dynamic, self-starter, accountable, assertive, multi-tasker, communicative, respected, resilient, energetic, creative and very driven.
- Advanced MS office skills.
- A Bachelor's degree in Engineering or similar field is highly desired.

Solutions Driven Ltd is acting as an Employment Business in relation to this vacancy.