Manager, Quality Management Systems

Work Schedule

Environmental Conditions

Job Description

Position Summary:

The Quality Management Systems (QMS) Manager should be a dedicated Quality champion with current knowledge and proven experience in improving and maintaining a Quality Management System to meet FDA Quality System Regulations ISO 13485 ISO 9001 and ISO 14971 standards.

You will be leading and managing a team of 5 dedicated employees (incl. a student assistant) working in the areas of: Training Complaints/Deviations Change Control and Audit. Aside from making daily decisions on priorities within a busy team there will also be involvement in tasks within its different operative areas.

When youre part of Thermo Fisher Scientific youll do challenging work and join a team that values performance quality and innovation. As part of a successful growing global organization all are encouraged to perform at our best. With the largest investment in R&D in the industry we give our people the resources and chances to create significant contributions to the world!

Key Responsibilities:

• Management of the QA team ensuring team welfare & development and meeting of KPIs
• Maintain and update the QMS system to ensure compliance with current regulations and standards.
• Manage customer-facing quality processes to provide timely and professional replies to customer complaints and requests for information.
• Act as the focal point for ISO Regulatory and Customer Audits of the Quality Management System.
• Manage internal audit programs and identify nonconformance observations and opportunities for improvement.
• Coordinate supplier quality processes including audits and agreements.
• Coordinate the corrective and preventative actions (CAPA) process and monitor its performance.
• Manage the Change Management process and ensure its the best that it can be
• Ensure site procedures align with divisional and corporate quality documents.
• Provide leadership in all Quality Management Systems activities such as Management Review process Training Change Management Process Corrective/Preventive Action system and Internal Audit programme.
• Inform management in a timely manner of changes/trends in the QMS regulations & standards.

Requirements/Qualifications:

• Management experience and good people management skills
• Strong Quality Assurance experience and familiarity with audit processes
• Experience in CAPA and in dealing with non-conformance and complaints
• Well organised and structured with tenacity to follow through
• Ability to effectively lead manage train and motivate a diverse group of employees.
• Ability to communicate effectively both verbally and in writing with a wide variety of internal and external customers.
• Appreciative leadership style and understanding of how to develop an inclusive work environment
• Proficiency in Microsoft Word Excel PowerPoint as well as fluency in Danish and English languages

Diversity in our teams is an important element to building an effective and agile working environment. Integrity Intensity Innovation and Involvement are our 4-i key values that we encourage in everyone who is part of our community. At Thermo Fisher Scientific each one of our 140000 extraordinary minds has a unique story to tell. And all contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.