Quality Expert for Medical Devices

  • Salary: 100-107 CHF per hour (all inc)
  • REF Number: 00050049
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 782 516 595
  • Date Published: 08.03.2021
  • Sector: Basel Area
  • Location: Basel, Experienced
  • Discipline: Technical - Validation

CK QLS are recruiting for a Quality Expert to join a company in the Medical Device (Combination Products) department for a global healthcare company at their site based in Basel on a contract basis for 12 months.

Quality Expert Role: The main purpose of the role will be to:

  • 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.
  • Manage quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies.

Further responsibilities will include:

  • Supporting Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients.
  • Leading project related activities (e.g. development of new tools, processes).
  • Writing/contributing to internal compliance policy and/or comment to regulations.
  • Leading and supporting direct reports in line with Novartis values and behaviour including objectives setting, performance evaluations, development planning and participate in recruiting process.

Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science.
  • Fluent German and English Skills, French is 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.

This is an excellentopportunity to join a leading pharmaceutical and medical device company.

Apply: For more information or to apply for this Quality Expert position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email jblackham@ckqls.ch, quoting job ref 50049.

Please could you send any correspondence in English.

It is essential that applicants hold entitlement to work in Switzerland.

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