telephone: +44 (0)1403 273370

Quality Engineer

Reference Number: 921469 | Salary: Competitive | Location: West Sussex, United Kingdom | Division: Scientific Permanent


Quality Engineer – Medical Devices

West Sussex – Competitive Salary

 

Our client is looking for a QA Engineer to support the QA function in implementing and maintaining systems to the highest standard.

The company

The company specialise in the design, development and manufacture of medical products and accessories. The company uses the latest technology as well as the highest quality materials and works closely with industry nurses, patients, care organisations and our international distributor network, to provide innovative products to improve the lives of people all around the world.

Key Responsibilities:

  • Undertaking Quality Audits (Internal, Supplier) against ISO 13485 / 9001
  • Maintain and report on quality metrics
  • Providing QA support and approval of CAPA and Non-Conformances
  • Responsible for logging, monitoring and closing audit actions, Internal, and Supplier
  • Assisting the business in closing CAPA and Non – Conformances
  • Assist in the improvements of QMS against ISO 13485
  • Support training to site staff on Quality System procedures as required
  • Ensure the QMS is adhered to and that ISO standard requirements are met and maintained
  • Manage or assist with customer complaints and complaint reporting
  • Assist with Corrective and Preventive Actions (CAPAs) and support CAPA teams as necessary
  • Contribute in Lean Manufacturing Six Sigma Projects and communicate progress to CI Management with regards to key KPIs
  • Assist with new material, Equipment, CSV and Process validation as necessary
  • Support Manufacturing to ensure quality issues are dealt with and closed out in a timely manner.
  • Conduct Incoming Inspection sampling and analysis of raw materials
  • Calibrate Production Equipment as necessary in a timely manner and maintain the calibration database.

 

Experience

 

  • Experience of working within a QA role
  • Experience of maintaining ISO 13485 accreditation
  • Experience in developing and deploying Quality Assurance best practices, policies, procedures and processes.
  • Working in a large batch manufacturing environment, preferably medical device manufacture.
  • Management of waste reduction programs and reject data collection
  • Use of Lean and 6 sigma tools and techniques
  • DoE (Design of Experiments)
  • 8D
  • Corrective and preventive actions (CAPAs).
  • Continuous improvement (CI) projects
  • Customer complaints and complaint reporting.
  • Sampling and analysis of raw materials, WIP and finished products as required.
  • Change Control.

 

Qualifications

 

  • HND or preferably Degree qualified in Mechanical Engineering, Manufacturing or Materials Science.
  • DFMEA, SPC and root cause analysis.

 

Key words

Quality Assurance, QA, Engineer, Manufacturing, lean, management system, manufacturing environment, 6 sigma, quality, continuous improvements, medical device, MDD, ISO13485, 13485,

Harris Lord are acting as an employment agency on behalf of this company

 


Contact: Josh Hemsley

Keywords: Quality Assurance, QA, Engineer, Manufacturing, lean, management system, manufacturing environment, 6 sigma, quality, continuous improvements, medical device, MDD, ISO13485, 13485,


Apply For This Job
View More Jobs