Medical Device QA-QC Expert

Basel-City  ‐ Onsite
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Description

QA/QC Expert for Medical Devices - Switzerland - 6 months

Our client, one of the leading companies within the Life Sciences worldwide is currently seeking a Medical Device Quality Expert.

As a medical device quality expert, you will be ensuring technical development and manufacturing operations of assigned Medical Devices/Combination Products are conducted in accordance with company requirements, ensuring high product quality, regulatory compliance and operational efficiency.

Major tasks and requirements
  • Manage portfolio of assigned projects, support a discipline and/or provide a service on his/her own or with a team of associates. Provide functional expertise in area of responsibility for medical devices and combination products.
  • Write, Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance.
  • Accountable for monitoring, analysis and reporting of GMP related KPIs as part of management reporting.
  • Manage quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies.
  • Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients.
  • Perform or support inspections and audits as required.
  • Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority requirements, SOPs, HSE, etc.). Promote and enforce compliance to guidelines. If managing associates, ensure same for them.
  • Support project management functions as a sub-team member in preparation for a Pre-Approval Inspection
  • Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science
  • English fluent in speaking / writing. German and/or French desirable
  • Excellent knowledge of cGMP, working knowledge of medical device and combination product regulations, standards and guidelines
  • Good knowledge of medical device development and life-cycle management
  • Relevant working/residency permit or Swiss/EU-Citizenship required


I am a specialized recruiter, currently taking care of various projects within the Life Science area in Switzerland. If this role is of interest to you or to someone from your network, please send your CV in Word including your hourly rate expectation for immediate consideration.

You can reach me on or at (a.xenitidis'at'realstaffing.com)

Keywords: medical devices, quality expert, medical devices, GMP, cGMP, risk management, English, quality
Start date
09/2016
Duration
6 Months
From
Real Staffing
Published at
25.08.2016
Project ID:
1192136
Contract type
Freelance
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