QA Engineer
other jobs Lynx Recruitment Ltd
Added before 2 Days
- England,London,City of London
- Full Time, Permanent
- £40,000 - £50,000 per annum
Job Description:
About UsWe’re a working with an exciting MedTech company dedicated to advancing orthopaedic care through innovative medical device solutions. Their products improve patient outcomes and quality of life, and we’re looking for a talented QA Engineer to help us maintain the highest standards of quality and regulatory compliance.
As a QA Engineer, you’ll play a critical role in ensuring our orthopaedic products meet regulatory requirements and quality standards. You’ll work closely with R&D, manufacturing, and regulatory teams to maintain our Quality Management System and support our growing portfolio of cutting-edge medical devices.
Key Responsibilities*Support FDA and CE Mark regulatory submissions and ongoing compliance activities
*Maintain and improve our Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards
*Prepare for and participate in internal and external audits, including FDA inspections and Notified Body assessments
*Review and approve quality documentation, including DHFs, DMRs, and technical files
*Investigate non-conformances and support CAPA processes
*Provide quality oversight for additive manufacturing processes, ensuring compliance with regulatory requirements
*Conduct supplier audits and manage vendor quality performance
*Support design control activities and product development projects
*Drive continuous improvement initiatives across the quality function
Essential Experience*Proven experience in a QA role within the medical device industry
*Strong working knowledge of FDA regulations (21 CFR Part 820) and CE Mark requirements (MDR/IVDR)
*Experience preparing for and managing regulatory audits and inspections
*Hands-on experience implementing and maintaining a Quality Management System (ISO 13485)
*Familiarity with additive manufacturing processes and associated quality considerations
*Understanding of orthopaedic or implantable device regulations (desirable)
As a QA Engineer, you’ll play a critical role in ensuring our orthopaedic products meet regulatory requirements and quality standards. You’ll work closely with R&D, manufacturing, and regulatory teams to maintain our Quality Management System and support our growing portfolio of cutting-edge medical devices.
Key Responsibilities*Support FDA and CE Mark regulatory submissions and ongoing compliance activities
*Maintain and improve our Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards
*Prepare for and participate in internal and external audits, including FDA inspections and Notified Body assessments
*Review and approve quality documentation, including DHFs, DMRs, and technical files
*Investigate non-conformances and support CAPA processes
*Provide quality oversight for additive manufacturing processes, ensuring compliance with regulatory requirements
*Conduct supplier audits and manage vendor quality performance
*Support design control activities and product development projects
*Drive continuous improvement initiatives across the quality function
Essential Experience*Proven experience in a QA role within the medical device industry
*Strong working knowledge of FDA regulations (21 CFR Part 820) and CE Mark requirements (MDR/IVDR)
*Experience preparing for and managing regulatory audits and inspections
*Hands-on experience implementing and maintaining a Quality Management System (ISO 13485)
*Familiarity with additive manufacturing processes and associated quality considerations
*Understanding of orthopaedic or implantable device regulations (desirable)
Job number 3385825
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Company Details:
Lynx Recruitment Ltd
Company size: 1–4 employees
Industry: Recruitment Consultancy
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