|Job Title:||Quality Engineer|
|Salary:||€40000 - €50000 per annum|
|Contact Name:||Rachel Radford|
|Job Published:||January 23, 2017 13:43|
Your responsibilities will include but not be limited to:
- Manage direct reports including: develop and retain talent; establish and maintain clear roles and responsibilities; ensure adequate resource utilization.
- Support the maintenance of an effective Quality Management System that complies with international standards and relevant regulatory requirements
- Understand new regulations and guidelines, and implement systems and procedures to incorporate these new regulations.
- Establish, track and respond to leading and lagging Quality Key Performance Indicators (KPIs).
- Provide Quality Engineering and Statistician contributions to cross-functional project teams that develop and/or transfer new diagnostic products under Design Control processes.
- Provide Quality Engineering and Statistician contributions for the approval and implementation of Design Changes to existing products and processes.
- Provide Quality Engineering and Statistician contributions and approval for product stability/monitoring programs.
- Provide Quality Engineering and Statistician leadership to CAPA and other investigations; maintain and develop functional expertise in: product and process technology, investigations, Root Cause Analysis, report writing, statistical data analysis, and implementation of actions arising from CAPA processes.
- Responsible to ensure that all released products meet the release testing processes, criteria and specifications. Responsible to understand how the release specifications trace to the product Design History File.
- Track and trend quality control and release testing data for all product lines; statistical process control engineering; trend alerts; Cp and CpK metrics.
International travel (up to 20%) may be required.
Qualifications / Experience
- Primary degree qualification in a science, engineering or business discipline.
- Minimum 6 year experience in in vitro diagnostics or related industry.
- Design control and design transfer
- Process engineering
- CAPA and other investigations involving root cause analyses
- Successful implementation of continuous improvements to QMS
- Project management of change programs
- Building and leading effective teams, and highly motivated individuals
- Skills and Behaviours
- Excellent verbal and written communication skills.
- In-depth knowledge of International Standards, GLP and GMP.
- Ability to successfully implement change.
- Ability to manage complex projects involving multiple functions.
- Strong technical and analytical/problem-solving skills
- Ability to collaborate with and influence groups in a positive, team‑based environment
If you are intereste in this role please don't hesitate to apply!
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