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Quality Systems Engineer
Quality Control
Medical Development and Manufacturing Solutions Provider
Denmark , CopenhagenJob Description
- Work closely with global sites to implement the Quality Management System standardization and integrate with the ERP system implementation and maintenance.
- Develop meaningful metrics to gain understanding of current state of QMS and manage the monthly KPI review process
- Participates in audits and regulatory inspections
- Provide GMP guidance to facility personnel
- Support product compliance by working with the Quality organization.
- Evaluate processes for updating techniques, quality and overall efficiency to improve operations
- Instill a mindset that will proactively cause those involved in the business to put all GMP regulations at the forefront of their day-to-day activities
- Regularly research and evaluate regulatory trends to insure the compliant systems
- Provide periodic status updates and reports
- Reviews regulatory, program and customer requirements ensuring early quality involvement in program development
- Travel to PMC facilities as required to support business needs
Job skills
- BS plus a minimum of four years of related experience within a regulated environment, or equivalent industry experience
- Knowledge of GMPs Regulations (13485, 820, 210/211, EU)
- Internal Auditor (external lead training preferred)
- Strong communication, teamwork, and organizational skills
- Ability to manage small projects/programs with limited assistance from others
- Knowledge of FDA Quality System Requirements, ISO 13485, ISO 9001, ISO 14971
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Work schedule
Continuous shift -
Contract type
Full time -
Experience
From 1 to 3 years