Medical Devices - Design Quality Engineering

Paris, Île-de-France, France / Lyon, Rhône-Alpes, France / Rhône-Alpes, Grenoble, France
£40662.45 - £54216.60 per annum
06 Jan 2021
20 Jan 2021
Alessandra Gheza
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Medical Devices - Design Quality Engineering

At I-Pham Consulting, we are collaborating with an international company, which develops and produces medical devices

This is a fantastic opportunity for a person who wants to be part of a dynamic and ever-expanding world.

Ideal for a person who wants to:

  • Be part of an international company part of a larger group
  • Work with an international team
  • Work on exciting projects and cutting-edge technologies

Title: Design Quality Engineering

Location: France


  • Risk Management oversight, plan and risk assessment activities to minimise potential risk during development and implementation (DHF/DFMEA/PFMEA/Health Hazard Evaluations)
  • Integrate design files into the Quality System ensuring transferred systems understanding within the team, ensuring compliance with documented Quality System (FDA QSR's and ISO 13485/9001
  • Support the product post-market surveillance process (Quality perspective)
  • Liaise with R&D to ensure CTQ (Critical To Quality) specifications are agreed and documented
  • Ensure that the latest technology is available to reduce human factor leading design for inspection activities for all NPD
  • Ensure statistical support for DOE (Design of Experiments), sampling plans, capability assessments, rationale development & hypothesis tests as required
  • Ensure effectively problem-solving during investigations (CAPA) as required and define through negotiation corrective actions


  • Assist the Quality Systems Manager and Compliance Manager to manage the regulatory compliance program to include FDA and BSI
  • Working with stakeholders to support and lead in the NC and CAPA investigations to solve design and process issues - partner with affiliated disciplines (R&D, Regulatory Affairs, Clinical Affairs)
  • Assist in resolving all quality issues, allowing the transfer of manufacturing processes to Operations
  • Approve design specifications (e.g. drawings, protocols) as defined for own scope of responsibility.


  • Degree in Mechanical Engineering, Industrial design or similar
  • 5 years in a QA role for a regulated company, Quality Systems maintenance
  • Ability to introduce new product development in the medical device industry
  • Knowledge of FDA and MDD GMP
  • Knowledge and understanding of validation techniques: risk assessment, validation planning, IQ, OQ, PQ, change control and process verification
  • Experience of internal audit, CAPA and operational management review
  • Good understanding of geometric dimensioning, tolerancing and engineering drawings
  • Experience in creating engineering specifications, procedures
  • Experience in mechanical engineering processes
  • PC literate, familiar with MS Office

About i-Pharm Consulting

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

To apply

If you would like to discuss this vacancy further, please contact Alessandra Gheza.

Tel. +44 (0)2031890464


If this role is not suitable, Alessandra is also available to discuss other possible positions or answer any general questions regarding your career and the current market.