​Medical Device Quality Engineer - Project Lead - Technical Documentation

Discipline: Quality Assurance
Job type: Permanent
Salary: £Competitive Salary - Depending on experience
Contact name: Katie Dunbar

Contact email: Katie.Dunbar@rbwconsulting.com
Contact phone: 01293584300
Job ref: 21913
Published: about 1 month ago
Expiry date: 01 August 2021

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.

Position Requirements:

  • Support as Quality Engineer (QE) which includes:

    • Executing local QMS requirement

    • Document creation / approval

    • FAI preparation

    • NC/CAPA support

    • 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.

  • Tech-Doc compilation

  • 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 katie.dunbar@rbwconsulting.com or +441273 952176 to find out more.

Competitive Salary - Depending on experience