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Quality Engineer for Post Market Surveillance (m/w) in Solothur

Quality Engineer for Post Market Surveillance (m/w) in Solothur

Job Title: Quality Engineer for Post Market Surveillance (m/w) in Solothur
Contract Type: Permanent
Location: Solothurn,
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: SPPO3101
Contact Name: Petra Ognjenovic
Contact Email: p.ognjenovic@sciproglobal.de
Job Published: January 31, 2017 12:32

Job Description

Quality Engineer for Post Market Surveillance (m/w) in Solothurn

Our client is one of the largest, most comprehensive orthopedic and neurological companies in the medical devices industry. Currently we are looking for a

Quality Engineer - Post Market Surveillance

As Quality Engineer, you would be responsible for following Tasks:

Tasks

  • generate and coordinate Post Market Surveillance (PMS) activities
  • perform sustaining Design Quality Engineering activities with Focus on Biomaterials
  • Perform PMS activities including trend analysis, signal assessments and product investigations
  • Execute the PMS process with a primary focus on signal assessment and detailed investigations of potential safety issues and quality trend events
  • Interface with key business partners and coordinate activities as determined by the safety surveillance processes of Product Development, Medical Affairs, and Regulatory Affairs, Operations, Marketing and the Complaint Handling departments
  • Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
  • Support quality improvement initiatives that lead to continuous / cost improvement

Qualifications

  • A minimum Bachelor's degree in a technical discipline is required with Engineering being the preference
  • A minimum of two years' experience working in a quality system framework is required
  • Medical Device/diagnostic/ pharmaceutical industry experience is preferred
  • Root cause analysis skills preferred
  • Strong working knowledge of the QSR and ISO quality requirements is a plus
  • Knowledge of process design excellence tools with Green or Black belt training is preferred
  • Experience with Post Market Surveillance /Safety Surveillance activities preferred
  • Previous Design Control experience is a plus
  • Excellent communication skills at all levels
  • Ability to communication complex subjects in a business appropriate manner
  • Good oral and written English language skills are required, German is a plus

Are you motivated, committed and flexible? Do you enjoy taking the initiative and working independently? Do you have a highly developed quality awareness? Do you work conscientiously, and are you resilient to stress? Then please send your complete application documents by email to Petra Ognjenovic: p.ognjenovic@sciproglobal.de

In case of any further question, please do not hesitate to contact

Petra Ognjenovic: 0049 89 2109 4906.