Verification Engineer in Basel

veröffentlicht
Kontakt
Mischa Camen, Zürich Professionals IT
Jobtyp
contract
Jetzt bewerben

job details

veröffentlicht
Ort
Basel, Basel-Stadt
Sektor
Engineering
Jobtyp
contract
Referenznummer
10079
Kontakt
Mischa Camen, Zürich Professionals IT
Telefon
058 201 56 60
Jetzt bewerben

Stellenbeschreibung

Verification Engineer (main focus of documentation)

Currently we are looking for a Verification Engineer which mainly responsible for the generation and management of experimental and cGMP verification activities providing objective evidence that the medical device/combination products perform according to patient`s and technical needs.


Your Responsibilities:

  • Translate cGxP and normative requirements (e.g., USP, Ph. Eur., ISO, ASTM) into practical lab processes (e.g. test sample management, test method validation and transfer, discrepancy management and OOS, training, change management, complaints) including practical development, implementation, documentation.
  • Author of protocols, rationales and reports
  • Lead or support transfer of methods into clinical and commercial facilities/packaging centers
  • Lead and track Change Control activities for Test Methods and Lab Processes, Assess impact of changes (internal or external) on test method validation and compliance of existing lab processes
  • Support management during internal/external Quality inspections of Verification Engineering Labs and help define appropriate responses
  • Support the development and completion of robust, risk-based, medical devices / combination products verification strategies.
  • Write, review, approve design verification plans, protocols and reports, support development of rationales justifying chosen approaches (e.g. acceptance criteria, statistical sampling, time points)
  • Analyze test data (design capability, trending, k-value)
  • Lead and track management of unexpected events (e.g., discrepancies, complaints) for these medical devices/combination products within cGxP regulated area

Requirements:

  • Bachelor, Master in Engineering or Science discipline (pharmaceutical/ natural/biomedical/materials science or a related field)
  • Process oriented and analytical thinking (sensibilisation to lean 6s techniques highly desirable)
  • 2-5 year track record and experience in and characterization of medical device/combination products, special/innovative packaging, or compact, complex, multi-material hand-held products
  • Experience of working in Pharma or Medical Device (cGxP, QSR) or other closely-regulated environment
  • Sound knowledge of legislation, regulation, industry standards and guidance around the area of combination products and medical devices
  • Root Cause Analysis

If your Profile matches the requirements above we are looking forward to receive your full application.