Quality Engineer / £40-45k
- Location: Chertsey
- Hours: Standard day shift - flexible start finish times (8/8:30am - 5/5:30pm)
- Interview: Slots available
- Start: As soon as possible (we appreciate people may be on a notice period)
- Duration: Permanent, full time position
About the Role
Syntech Recruitment are proud to partner with a superb MedTech business who have recently integrated their manufacturing processes on site, we are seeking a Quality Engineer to establish and enhance the quality assurance processes, ensuring compliance and certification within the company.
Key Responsibilities
- ISO Accreditation: Maintain ISO9001 & ISO13485 accreditation.
- Certification Support: Collaborate with the design & development team to achieve CE/UL mark certification efficiently.
- eQMS Management: Oversee the electronic Quality Management System (eQMS), including its creation, development, and continuous improvement, ensuring alignment with the production team.
- Audit Development: Develop and conduct all required ISO audits.
- Compliance Authority: Serve as the point of contact and responsible authority for all registered products, including CE, MHRA, EUDAMED, etc.
- Quality and Safety Standards: Work with the production team and design engineers to enhance and maintain quality and safety standards, performing hands-on inspections when necessary.
- Non-conformance Management: Manage non-conformance reporting and supplier returns, working with engineers to set specifications and tolerances for parts.
- Customer Issue Resolution: Collaborate with sales and technical support to thoroughly investigate customer issues, trace root causes, and implement corrective actions.
- Quality Process Design: Design and implement quality processes across production, including setting standards for documentation such as work instructions, process records, document control, and electronic data management, including test records.
- Quality Metrics & KPIs: Establish manufacturing quality metrics & KPIs with a strong emphasis on Lean Six Sigma and problem-solving methodologies.
- QC Inspection: Perform hands-on quality control inspections from goods-in to finished goods.
Experience and Skills Required
- Quality Assurance Expertise: Essential experience in quality assurance and regulatory practices.
- ISO Accreditation Experience: Essential experience with ISO9001 & ISO13485 accreditation.
- Medical Sector Background: Ideal background in the medical sector.
- Manufacturing/Engineering Knowledge: Advantageous knowledge of the manufacturing or engineering sectors.
- Lean Six Sigma Proficiency: Strong understanding of Lean Six Sigma and problem-solving methodologies.
- Stakeholder Collaboration: Ability to effectively work with various internal stakeholders.
Location: Chertsey (no access by public transport, transport is needed to get to site)
Salary: £40-45k
Application Process: We aim to respond to all applicants within 5 working days. If you don't receive a response within this period, please consider your application unsuccessful.
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Syntech Recruitment Limited: We act as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. Our T&C's, Privacy Policy, and Disclaimers are available on our website: www.Syntechrecruitment.co.uk