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QA specialist – Global Medical Device Company

Job title: QA specialist – Global Medical Device Company
Contract Type: Permanent
Location: Zürich
Industry:
Salary: Competitive
Reference: BH-119468
Contact Name: Martin Ivanov
Phone Number: 01
Job Published: 21 days ago

Job Description

QA specialist – Global Medical Device company

We are looking for a QA and Regulatory Affairs specialist currently working and with at least 5+ years’ proven experience in medical device development (from design to market).

Responsibilities

  • QMS, technical file and certifications maintained (including devices CE marking);
  • Application of Risk Management to Medical Devices ( ISO: 14971 );
  • Suppliers’ quality compliance;
  • Leading and implementing the internal and external auditing;
  • Changes recorded (CAPA resolution process);
  • Identify FDA process accreditation requirements.
  • Initiate the accreditation process for medical device software ( IEC: 62304 ).
  • Maintain up to date knowledge of laws standards and regulations.
Experience:
  • Quality Assurance medical devices: 5 years (Required)
  • Deep understanding of QMS culture in MedTech industry; you will lead company ISO quality standards throughout clinical trials and markets expansion (FDA & MDSAP area)
  • Understanding of manufacturing process control in both surgical CE marked and custom-made instrumentation areas is essential
  • Preferably with knowledge in AM process
Qualifications
  • Bachelor’s degree with scientific, engineering, regulatory, quality or legal core competency
  • 5+ years’ experience in a Quality Engineering, QA or Regulatory role in medical devices
  • Deep knowledge of ISO: 13485, ISO: 14971, FDA standards and certification processes
  • Experience of supporting new product development in a quality role
  • Must have sufficient knowledge to act as the subject matter expert within the development team for new digital MedTech products
  • Excellent PC skills, including QMS and Microsoft Office applications
  • Organisational and problem-solving skills
  • Strong written communication skills: plans, procedures, work instructions and reports
  • Self-motivated with innate leadership attitude
Desirable:
  • Software validation process IEC: 62304,
  • MDR and MDSAP knowledge,
  • Bilingual or with good knowledge of a second language.
Benefits:
  • Flexible working hours
  • Bonus scheme
  • Work from home opportunities
  • Profit sharing/share options
Experience in within the EU is needed. Please note we can only accept applications from candidates who hold valid European Union passport and are able to work in Europe without visa sponsorship.

For a confidential discussion about quality assurance vacancies, then send your CV to me, Martin Ivanov, Senior Recruitment Consultant for Switzerland at martin.i.a2tui2z1v@nesgt.aptrack.co.uk