Job DescriptionQA 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).
- 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.
- 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
- 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
- Software validation process IEC: 62304,
- MDR and MDSAP knowledge,
- Bilingual or with good knowledge of a second language.
- Flexible working hours
- Bonus scheme
- Work from home opportunities
- Profit sharing/share options
For a confidential discussion about quality assurance vacancies, then send your CV to me, Martin Ivanov, Senior Recruitment Consultant for Switzerland at firstname.lastname@example.org