A highly innovative medical device manufacturer is actively looking for an experienced Supplier Quality Engineer to join their team. They are genuinely revolutionising certain applications within their field and the successful candidate will be working on high tech, innovative products which will have a huge impact on people’s lives.
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 componentry meets 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 GDP and 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 in a range of statistical techniques including; sampling techniques, Measurement System Analysis (MSA), capability analysis etc.; experience of using applicable s/w applications advantageous.
- Experience of risk management techniques including Failure Modes & Effects Analysis (FMEA).