Quality Assurance Compliance Expert

Vor 3 Tagen


Le Locle, Neuenburg, Schweiz Randstad (Switzerland) Ltd. Vollzeit

Job Title: Complaint Resolution Specialist

About Us

Randstad (Switzerland) Ltd. is a leading provider of recruitment and HR services in Switzerland. We help clients find the best talent for their organizations, while also supporting individuals in their career development.

Description

We are seeking an experienced Complaint Resolution Specialist to join our team in Neuchatel, Switzerland. As a Complaint Resolution Specialist, you will be responsible for investigating complaints, implementing and improving procedures related to complaints, tracking corrective/preventive/improvement actions, and participating in projects related to complaints activities.

The ideal candidate will have a minimum of 2 years of professional work experience within a quality assurance or compliance audit environment, with knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC MDD, EUMDR 2017/745, 21 CFR part 820, Chinese, Canadian, Japanese, Australian, Brazilian regulations, etc.

You will work closely with internal and external stakeholders to ensure adequate investigation of complaints and review risk files, identify root cause, DHR review, report writing, archiving, escalation to NC or CAPA when applicable.

Required Skills and Qualifications
  • Minimum of Bachelor's Degree in Quality Assurance, Engineering, Life Science, or related technical discipline.
  • Minimum of 2 years of professional work experience within a quality assurance or compliance audit environment.
  • Knowledge of Medical device standards and regulations.
  • Experience in a Medical Device manufacturing environment.
  • Training in laboratory techniques in medical devices.
Benefits

We offer a competitive salary and benefits package, including health insurance, pension plan, and paid time off.



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