Supplier Quality Engineer 348

ProductLife Group is growing and we are looking for the next member of the Medical Device international team :

Responsibilities

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO : Quality:
  • Drafting quality docs
  • SOP, WI templates
  • Managing supplier’s documentation (SCAR, NC etc)
  • Handling Supplier’s Audit
  • Ranking Suppliers evaluation
  • Handling Non Conformities on processes and material
  • Capability to handle CAPA entirely or part of it
  • Support internal and external audits
  • CE marking approval support
Regulatory:
  • Coordinating activities in order to handle Technical Documentation aspects
  • Tech file support draft
  • STED handling
  • Quality control plan
  • MDR proficient
Compliance activities
  • Involvement approval processes:
  • EU In country registrations
  • FDA Premarket approval (510K) support
  • MDSAP support preparation.

Education

  • Graduation MSC or PHD in scientific matters (Engineering, Chemistry, Pharma…)

Experience

  • At least 3/5 years of experience in medical Device field (or Strictly related)
  • Experience in quality assurance and compliance activities
  • Experience in regulatory affairs
  • Experience with a PLM documentation system is highly appreciated

Skills

  • Knowledge of standards ISO 13485 : 2016 / ISO 14971
  • Knowledge of regulations MDD 93/42 - QSR 21 cfr 820
  • Entrepreneurial spirit and proactive approach
  • Organization, autonomy and ability to prioritize
  • Proficient in English communication with Technical and non-Technical Stakeholders

Publish Date

11 November, 2021

Spontaneous Application

Supplier Quality Engineer 348

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

Apply