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Job Description
X4 are currently collaborating with a world leading Medical Device company in the search for a dedicated Quality Engineer to join their team based in Surrey, UK.
All candidates should make sure to read the following job description and information carefully before applying.
The incoming individual will be joining an established Quality team and will be responsible for ensuing all products and services meet quality standards.
Duties and Responsibilities:
- Perform inspections on products and services to verify adherence to established quality criteria.
- Update and manage quality system documentation in line with the organization document control procedures, ensuring documentation accurately mirrors current operations.
- Identify quality concerns, address them, and document incidents via the defect or CAPA system.
- Execute audits and risk evaluations to affirm quality standard compliance.
- Partner with engineering peers to integrate quality considerations into their workflows.
- Provide guidance and training to other quality staff members.
- Contribute to the development and upkeep of the quality management systems (QMS).
- Promptly initiate and track defect reports across all business segments, ensuring active follow-up in defect meetings.
- Analyse trends, assess risks, and log defect reports to uphold product integrity.
- Spearhead meetings focused on defects and design issues, ensuring swift resolution of supplier and design challenges.
- Assist in managing service and engineering related CAPAs.
- Oversee engineering change requests, reworks, and concessions, updating related processes and protocols as needed to maintain product quality.
- Provide quarterly FMEA reports to relevant parties, incorporating new concerns identified in defect/design meetings.
- Conduct monthly reviews of case information to guarantee comprehensive resolution.
- Provide regular updates to the Quality Supervisor on progress and developments.
- Tackle additional tasks as necessitated by the role.
Qualifications and Skills:
- A Higher National Certificate (HNC) in Engineering, Quality Assurance, or a similar discipline.
- A minimum of 2 years’ experience in a Quality Engineering position, with a preference for candidates with a background in the medical device sector.
- Proficient knowledge of ISO13485 quality management system standards.
- Practical experience with quality control, testing methodologies, and quality control technologies.
- A solid grasp of Failure Mode and Effects Analysis (FMEA) and Root Cause Analysis (RCA).
- Excellent organizational skills.
- Superior analytical and problem-solving capabilities.
- Effective communication and interpersonal abilities.
Please share you CV at e.smailes@x4 lifesciences.com if you are interested in hearing more about the position. As always if anyone in your network may be a good fit, please share their details as we offer a referral bonus upon the successful placement.