Manager, Quality Management Systems

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Position Summary:

The QMS Manager will play a crucial role in our ambitious team, ensuring our Quality Management System meets world-class standards! The ideal person for this role would be an individual with proven expertise and a drive to successfully implement and maintain flawless systems in compliance with FDA regulations and ISO standards. There is rich opportunity for the right person to influence this area as it develops and improves.

What will you do?

• Maintain and update the QMS system to ensure compliance with current regulations and standards.
• Manage customer-facing quality processes, providing timely and professional responses 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 programmes, identifying nonconformance observations and opportunities for improvement
• Coordinate supplier quality processes, including audits and agreements
• Coordinate the corrective actions and preventive actions (CAPA) process, and monitor its performance
• Manage the Change Management process and monitor its performance
• Ensure site procedures align with divisional and corporate quality mentorship documents
• Provide leadership in steering all Quality Management Systems activities, including 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 Quality Management System regulations and standards
• Other duties as needed.

Hiring Requirements/Qualifications:

We are looking for a well organized and structured person with the ability to effectively lead, manage, train and motivate a diverse group of employees. And also communicate effectively, both verbally and in writing, with a wide variety of internal and external customers.

• Min. 2 years' leadership or management experience
• Readiness to drive the achievement of department KPIs
• Appreciative leadership style and understanding of how to develop an inclusive work environment
• Experience in CAPA and in dealing with non-conforming products, and complaints
• Prior involvement and familiarity with internal/external audit processes
• Excellent communication and team-building skills
• Familiarity with ISO 9001 og ISO 13485 regulations
• Proficiency in Ms Word, Excel and PowerPoint

Nice-to-have Criteria:

• Experience with LEAN methodologies
• Familiarity with ISO 14971 framework

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please mention, when contacted, your required accommodation.