Medical Device Manufacturing Engineer - Project Lead-Packaging & Labelling

My client are seeking Quality Engineers with proven background in the Medical Device industry to join their European team.  This role could be based in France OR Ireland and is open to both permanent employees or contractors.

Reporting to the Orthopedic Manager, this role requires collaboration with internal teams and will be embedded on site with the external client.

POSITION REQUIREMENTS          

•             Leading the team regarding Packaging and Labelling conversions

•             Support as Manufacturing Engineer which includes.

o             Executing local QMS requirement

o             Document creation / approval

o             FAI preparation

o             NC/CAPA support

o             Managing Work in Progress

o             Product/Process assessment etc.

o             Support of Operations

•             Interact with cross-functional team

•             Organizing Pack & Label activities

o             Label prints

o             Label approvals

o             Label creation

o             FAIs

o             BOM Updates

o             WIP Management / Quality Gate Strategy

o             Process development (Country-specific labeling, Patient Implant Card, etc.)

o             Liaising with Supplier workstream to involve affected suppliers in the activities above.

•             Reporting out on the status (internal and external manufacturing)

QUALIFICATION AND SKILLS       

o             Engineering/Science license and 6 to 8 years work experience in Medical device industry

o             Engineering diploma (diplôme d'ingénieur) with 8 to 10 years of experience in Medical device industry

•             Medical Device packaging and labelling experience is essential.

•             Knowledge on supplier management and Process validation is essential.

•             Excellent communication skills and attention to detail.

•             Have a good understanding of engineering and Quality concepts.

•             Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.

•             Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.

•             Knowledge of ISO 13485/ EU MDR / 21 CFR part 820/ requirements desirable.

•             Lean Six Sigma training a distinct advantage.

•             Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).

•             Thorough knowledge and understanding of International Medical Device Regulations

•             Highly developed problem solving and strong analytical skills.

•             Team managing and multisite co-ordination.

•             Proficient in English (and French if applying for France)

Existing Right-To-Work in the EU is essential for this role, as sponsorship sadly cannot be considered.

Please apply with your CV or contact katie.dunbar@rbwconsulting.com or +441273 952176 to find out more.