QA Complaint / Post Market Surveillance Specialist

☞ Bio-Rad Laboratories

View: 157

Update day: 24-04-2024

Location: Fribourg Fribourg FR

Category: Serving / Cleaner / Maids PG / PB / Reception

Industry: Industrie manufacturière

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Job content

Présentation:

Our company is involved in the supply of high-quality products and services intended for diagnostic laboratories. Independence, innovation and commitment are the fundamental values that permeate our company culture, as well as a strong orientation towards our customers and a multicultural environment.

Bio-Rad in Cressier/Switzerland is looking for a QA Complaint/Post Market Surveillance Specialist.
Responsabilités:

Responsible to perform and follow up Post Market Surveillance (PMS) activities, providing leadership to apply and continuously improve the System in accordance with the Global QA strategy and in compliance with European (IVDR) and FDA requirements
  • You support the PMS activities and complaints handling process, and have the QA oversight of the product customer complaint management activities.
  • You lead the preparation of PMS plan and report, ensure timely analysis of the data.
  • You support the products support staff in managing and resolving complex complaints and initiate product quality actions (Hold, Field Action, Field Safety Notice) when needed.
  • You develop and track meaningful metrics to monitor process effectiveness and communicate results and product trends to internal stakeholders.
  • You provide leadership to continuously improve the Quality System in accordance with the Global QA strategy and in compliance with European (IVDR) and FDA requirements.
  • You participate to authority, notified body and customer audits. You participate to the internal audit program as Internal Auditor and to external audits as Quality Expert, especially for complaints system.
  • You support, when necessary, Quality Management System activities and projects as Quality referent for deviations, change control and CAPA or Project lead.
Compétences:

  • You have a master’s degree in biology, biotechnology, or similar field.
  • You show at least 5 years of experience in a similar position associated to/with complaint handling, preferably in a Diagnostic environment.
  • You have a strong knowledge and understanding of regulatory agency (cGMP/ISO) requirements, as well as IVDR requirements for Post market Surveillance activities.
  • You have ideally an expertise in Immunohematology and in quality systems.
  • You have a strong ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions. Experience in Lean or Six Sigma projects is an asset.
  • Fluent in French and English (spoken and written), German an asset.

Do you see your next professional challenge in this position? We look forward to receiving your application. If you click on "Apply", you have the option of submitting your complete cover letter, resume and credentials in a coherent PDF or Word document.


To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

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Deadline: 08-06-2024

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