QA RA Manager

QA RA Manager.

QA RA Manager

St. Gallen

|

Interim

|

Quality Assurance

Located close to the boarders of Switzerland, Austria and Germany, my client, a leading provider of high-quality solutions in the field of Medical Devices and In-Vitro Diagnostics is hiring for a QA/RA Manager to join them on a permanent basis. With a strong focus on innovation, quality, and regulatory compliance, we are committed to delivering products that meet the highest standards of performance and safety.

Responsibilities:

  • Assist in the registration and approval processes of medical devices globally, focusing on CE, FDA 510(k), and NMPA.
  • Continuously improve the Quality Management System according to ISO/EN 13485:2016 standards.
  • Establish and adapt to the Medical Device Single Audit Program (MDSAP) and make necessary adjustments in line with MDR 2017/745 requirements.
  • Coordinate and conduct audits.
  • Monitor product markets, prepare reports such as PSUR, manage changes, and oversee test equipment.

Qualifications:

  • Hold a degree in quality management or related field, or possess equivalent extensive experience in the industry.
  • Have at least 3 years of relevant experience, ideally in ophthalmology or the MedTech sector dealing with both durable goods and consumables.
  • Familiarity with Medical Device approvals (CE, FDA, NMPA) is required.
  • Proficiency in both German and English.
  • Exhibit independence, precision, and a systematic approach to work.
  • Display a technical aptitude and a keen interest in diverse systems.
  • Demonstrate responsibility, innovation, and a proactive attitude towards finding effective solutions.

If you are interested in applying or finding out more about this opportunity, simply click apply and send me your CV!

Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

We do not ask for a placement fee from Candidates/Employees.

If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09

James Prentice

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