Quality Engineer


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https://www.serlimited.com/6940-quality-engineer/business-support/essex/job2025-07-24 15:38:101970-01-01 SER Limited
Job Type Permanent Full Time
Location Southminster
Area Essex, England Essex England Southminster
Sector Business SupportManufacturing
Salary £40k per year
Currency gbp
Start Date ASAP
Advertiser remoteapi
Job Ref 104224
Job Views 70
Description

Quality Engineer - Medical Devices
Location: Southminster, Essex
Salary: £40,000
Job Type: Full-Time, On-Site

Are you passionate about quality and ready to take your next step in the medical device industry? A leading manufacturer is seeking a Quality Engineer to support the development and delivery of high-quality products across the full product lifecycle. This is a hands-on, full-time position based on-site at a modern facility in Essex - just a 2 minute walk from Southminster train station. 

About the Role


Reporting to the Quality Manager, you'll work closely with cross-functional teams to ensure quality is embedded at every stage of the process - from concept to production. You'll also act as a key point of contact for both internal teams and customers regarding quality assurance for a specific portfolio of products.

Key Responsibilities




  • Act as the Quality Assurance liaison for internal teams and customers


  • Support validation and verification activities, both internal and customer-led


  • Define in-process inspection criteria using process outputs


  • Assist with the creation and maintenance of product Technical Files (CE/UKCA)


  • Contribute to the improvement of internal processes and the Quality Management System


  • Lead problem-solving activities (e.g. RCA, CAPA, 8D)


  • Manage change control processes in line with quality requirements


  • Support internal and supplier audits, ensuring corrective actions are implemented


  • Promote quality awareness across the business and assist with training activities


What We're Looking For




  • Experience working within a regulated industry (medical device, pharmaceutical, or similar)


  • Qualification in an engineering or technical discipline


  • Knowledge of standards such as ISO 9001, ISO 13485, MDD/MDR, CFR Part 820, ISO 14971


  • Hands-on experience with quality tools and techniques (FMEA, RCA, CAPA, 5 Whys, APQP, etc.)


  • Familiarity with Technical File generation and maintenance for CE/UKCA marking


  • Excellent communication, time management, and organisational skills


  • Proficiency in statistical analysis tools (e.g. Minitab)


  • Lean Six Sigma experience is desirable


Working Conditions




  • Occasional work in a cleanroom environment with full PPE required


  • On-site role only - this position is not suitable for remote or hybrid working


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