Senior Quality Systems Specialist

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. Switzerland
Zürich
Posting date: 20 Feb 2019
QA.JV.21806_1550687827

ProClinical are advertising a Senior Quality Systems Specialist vacancy with a multinational medical device manufacturer. This company is at the forefront of biomaterials, musculoskeletal, instruments, and other orthopaedic technologies, and is seeking for the incumbent to the role to join the team in Switzerland.

The Systems Specialise will optimise added value and business success by reviewing, maintaining, operating, and further developing company processes. They will utilise appropriate tools to develop effective strategies to improve the performance of the quality system and develop relationships with key stakeholders to identify emerging needs.

Job Responsibilities:

  • Overseeing CAPA administration and acting as resident Expert for CAPA.
  • Developing and implementing quality system strategies to improve the performance of the quality system.
  • Working with operational groups to generate plans to solve quality system issues and implement improvements.
  • Carrying out internal and external system audits.
  • Reporting CAPA related metrics and preparing CAPA information for Management Reviews.

Skills

  • A technical degree.
  • 6 years of experience in a quality organisation of a manufacturing industry (preferably medical devices or pharma).
  • Thorough knowledge of applicable Regulations and Standards, in particular ISO13485, ISO14971, the Medical Device Directive 93/42/EEC, US Quality System Regulations (QSR), and Canadian Regulation (CMDCAS).
  • Auditor training with Certification examination.
  • Good problem-solving ability and analytical skills, strong sense of initiative, follow-through, and attention to detail.
  • Can conform to shifting priorities, demands, and timelines.
  • Good problem-solving ability and analytical skills, strong sense of imitative, following-through, and attention to detail.
  • Can conform to shifting priorities, demands, and timelines.
  • Flexible during times of change.
  • Experience of working both independently and in a team-oriented, collaborative environment is essential.
  • Excellent English and German skills.
  • Familiarity with a variety of office software packaged including MS Word, PowerPoint, Visio, Excel, SAP, and MS Project, and able to learn new technologies quickly.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Josh Volpe on +44 203 800 1292 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-JE1

close