Sterility Assurance Specialist for Medical Device in Zuchwil

Olivier Worch, Basel Professionals Health Care & Life Sciences
jetzt bewerben

job details

Zuchwil, Solothurn
Life Sciences
Olivier Worch, Basel Professionals Health Care & Life Sciences
058 201 55 50
jetzt bewerben


Randstad Professionals is currently looking for a Sterility Assurance specialist (Medical device) who will be assigned an interesting contract for a major client based in Solothurn.   This contract is an unique opportunity to join a major client, global group focusing on the Healthcare sector. 

The initial assignment will start immediately and will last until December 2018.

Job description:

Responsibility for Sterility Assurance Specialist with focus on European Sterility Assurance (Sterilization guidelines)

The role  will include

- Ensure compliancy to new European MDR

- Review/maintain/develop procedure tools and methodologies for Sterility Assurance programmes

- Ensuring compliance to applicable Medical Device Directive (MDD) and ISO 13485 /ISO 14971 /ISO 9001 and FDA QSR compliances.

- Maintain knowledge of FDA & ISO Sterilization guidelines.

To be the successful candidate you should bring: 

  • A Bachelor of Science Degree is required. A Master of Science or PhD is preferred.

  • Minimum of 5 years experiences in support of medical devices delivery, biology, pharmaceutical, or similar regulated industry.

  • Proven knowledge of FDA and MDD GMP requirements or standards regarding medical Devices (especially FDA/ISO Sterilization guidelines) 

  • Experience with GMP environments, particularly sterilization processes, microbiological testing.

  • Well known with critical design features for clinical reprocessing

  • Proven knowledge and ability regarding product verification and process validations.

  • Good interpersonal, organizational and oral and written communication skills


If you are interested for this great role, don't hesitate to send your application or to contact me directly.  I am looking forward to sharing informations with you. 

Olivier Worch Consultant Life Sciences T +41 58 201 55 55