Supplier Quality Engineer

2 weeks ago

Cardiff, United Kingdom IntaPeople Full time

The successful Quality Engineer will be responsible performing supplier quality engineering activities supporting safe, efficacious and compliant development and sustainment of the organisation’s medical device designs and manufacturing processes.

Duties & Responsibilities
- Establish, maintain and execute the means of evaluating, including site auditing, and approving; the quality/regulatory aspects of vendors to maintain a compliant approved external supply base in the best commercial interests of the company
- Co-ordination, review and approval of internal and external component qualification effort, including coordinating conduct of; metrology, measurement system analysis and capability assessments to ensure ongoing confidence that all externally supplied componentrymeets predefined design requirements, in a compliantly documented manner
- Co-ordinate the supplier corrective action request system to ensure the timely resolution and closure of vendor related quality issues
- Support vendor communication and improvement activity, using problem solving tools, to continuously improve the quality and cost of vendor supplied product and service
- Compile metrics relating to vendors quality performance; to support provision of vendor performance analysis to top management
- Support the Quality Engineering Manager coordinating tasks and supervision of resource to optimise the effectiveness of quality engineering work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of GDPand GMP.
- Adhere to the standards of behaviours, policies and procedures as laid out in the Employee Handbook.
- All other duties as required

Skills & Experience
- HND qualification or equivalent in engineering, science, or technology discipline.
- Lead Auditor qualification (ISO 9000 series-based quality system essential, ISO13485 preferred).
- Experience of quickly evolving environment with cross functional team working.
- Ability to interpret technical standards, technical drawings and specifications with a good understanding of metrology and other measurement considerations.
- Excellent report writing and presentation skills, good verbal communication skills.
- Experience of risk management techniques including Failure Modes & Effects Analysis (FMEA).

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