Quality Assurance Manager

Join our team at the Tech Lab site, part of the SSI Diagnostica Group, as a Quality Assurance Manager and help shape the future of healthcare technology. We are seeking multiple candidates that are experienced leaders to oversee critical projects in the medical device industry. This is an opportunity to contribute to meaningful innovations in a collaborative environment focused on improving patient outcomes.

We are a global company specializing in the design, development, and manufacture of IVD medical device kits. Our mission is to improve patient outcomes and transform healthcare delivery through technology and a commitment to quality. Our portfolio includes solutions for infectious disease, respiratory conditions, and blood-borne illnesses. We foster a culture of collaboration, continuous learning, and professional growth.

The job of Quality Assurance Manager entails the direct supervision of all Quality Assurance and Document Control personnel. The Quality Assurance Manager will be responsible for the maintenance of the quality system as well as maintaining compliance with regulatory requirements. The Quality Assurance Manager will report to the Vice President of Global Quality Assurance and oversee Document Control and Quality Assurance Supervisors, Officers and Assistants.

• Ensure compliance of the Quality Management System to all global regulatory requirements.
• Local implementation of global initiatives for compliance and process improvements
• Management of local Quality Assurance Team
• Duties for Quality Management Representative within local Quality Management System and to report state to management
• Oversight of releasing raw materials, components and finished products lots
• Ensure Non‑Conformities and Corrective and Preventive Actions are identified, investigated, and controlled
• Ensure company Training requirements/competencies are documented and current
• Oversight of Document Control Program
• Oversight of Validation Program
• Oversight of the Stability Program
• Oversight of Supplier Management
• Providing information/documentation to support Annual Management Review
• Hosting internal and external audits

• B.A. or B.S. in a life sciences + 10 years of experience with 3 years supervisory experience in GMP/QSR environment.
• Strong track record of developing and implementing QMS frameworks in regulated industries.
• Excellent leadership, communication, and collaboration skills; proven ability to influence across functional boundaries.
• Experience effectively managing and motivating resources to attain company and team goals.
• In-depth knowledge of Quality Management Systems (QMS) and relevant industry regulations.
• Background in continuous improvement with demonstrated results in cross functional collaboration
• Ability to analyze complex quality issues, identify root causes, and implement effective corrective actions.
• Proven ability to handle and resolve quality-related challenges in a dynamic research and manufacturing environment.