Locations: Grenoble, France OR Macroom, Ireland
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 Grenoble, France or Macroom, 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.
Support as Quality Engineer (QE) which includes:
Executing local QMS requirement
Document creation / approval
Product/Process assessment etc.
Leading the team regarding Tech-Doc submission
Serving as the main interface to RA for Tech-Doc
Manufacturing Data Collection which includes.
Gathering data from the local ERP, CAQ, PLM system
Collecting data from local/hard copy sources
Following up “breadcrumbs” to find the right information.
Deciding which information is correct as it makes sense from a product perspective.
Bringing the collected information into a form, required by the regulatory team for Tech-Doc submission
Gap Assessments/ Gap to Standards
Facilitating and tracking gap closure activities
Potentially triggering NC/CAPAs
Liaising with Supplier workstream to incorporate supplier information into the activities above.
Reporting out on the status (internal and external manufacturing)
Qualification and Skills:
Engineering/Science license and 6 to 8 years work experience in Medical device industry
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.
Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
Must be willing to work as part of a multi-site team.
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.
Project Management training or skills.
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 firstname.lastname@example.org or +441273 952176 to find out more.
Competitive Salary - Depending on experience
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