Quality Management Systems Expert
vor 2 Monaten
Job Overview
The position of Quality Management System Specialist is responsible for ensuring compliance with all applicable regulations, including cGMP. As part of the global quality assurance function for the Site Quality system, the job holder will provide guidance to multiple departments regarding compliance with the applicable SHL Site Quality and Regulatory procedures, including Agency policies and regulations. The job holder will be directly involved in the establishment of Site procedures.
Main Responsibilities:
- Develop and maintain the Site Quality Management System
- Oversee the implementation of quality assurance procedures
- Lead internal and supplier audits
- Support external audits
- Track key performance indicators (KPIs)
- Lead and contribute to Corrective Action and Preventive Action (CAPA) and Non-Conformance (NC) processes
- Contribute to site Quality Assurance, Regulatory, and Auditing (QARA) projects
- Provide training on quality assurance procedures
- Supplier qualification, including conducting supplier audits
Minimum Requirements:
- Minimum of 3 years' experience in Regulatory Affairs, Clinical Affairs, or Quality Assurance of medical devices
- Previous experience in quality processes for medical devices
- Experience in GMP and other Regulatory compliance requirements
- Analytical and problem-solving skills
- Operates in a way that never compromises ethics and integrity
- Ability to understand and adapt to different cultures and market needs
Preferred Qualifications:
- Certified internal auditor to ISO 13485
- Previous experience in quality management systems for medical device manufacturing organizations
Education and Training:
- Bachelor's degree in Life Sciences, Engineering, or a related field
- Certified Lead Auditor for ISO 13485 standards
We Offer:
- An exciting opportunity in a fast-growing international medical device company
- A modern working environment, with multicultural and dynamic teams
- Flexible working hours and a hybrid remote work policy
- A centrally located office in Zug, very close to the train station
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