Quality Engineer

2 weeks ago

Chertsey, United Kingdom Syntech Recruitment Ltd Full time

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.
Privacy and Data Retention: By applying to this position, you confirm your consent to the retention of your personal data. The data you provide will only be used for recruitment purposes, stored securely, and treated as confidential in compliance with our Privacy Policy.
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: (url removed)

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