Medical Devices - Design Quality Engineering

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

Responsibility

• 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

Other

• 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.

Essential

• 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.

www.i-pharmconsulting.com

To apply

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

Tel. +44 (0)2031890464

Email: agheza@i-pharmconsulting.com.

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.