Clinisys is a global provider of intelligent diagnostic informatics solutions and expertise designed to redefine the modern laboratory, across healthcare, life sciences, and public health. Millions of diagnostic results and data insights are generated every day using Clinisys’ platform and cloud-based solutions in over 4,000 laboratories across 39 countries. Our 1,450+ expert professionals, headquartered in Woking, UK and Tucson, Arizona, have a shared mission to enhance the effectiveness of diagnostic workflows in any laboratory or testing environment and keep citizens and communities healthier and safer.

Role Description:

This role is the quality owner of the product development and lifecycle management process. Works closely with Product Development and Support to ensure smooth product launches and efficient on-market delivery and support.

Support the organisation in conducting and documenting product and enterprise risk assessments that could impact or impede the safety, security, and functionality of Clinisys products or services.

Provide guidance for the improvement of business processes, products, software systems, training and reporting of metrics and trends in accordance with internal and external regulations, policies, and procedures.

Investigate and document actions to address complaints including notifications to customers and regulatory authorities.

Responsibilities:

• Generate and update Device History Files: design inputs (user needs, product requirements), product specifications, risk traceability matrix.
• Leadership of global, cross-functional teams to align on requirements and specifications, troubleshooting issues, resolving issues, implementing corrections.
• Project management of multiple timelines and products simultaneously.
• Support the implementation, maintenance, and evolution of the Integrated Quality and
• Information Security Management systems under ISO 13485, 9001, 14971, and 27001.
• Establish policies and procedures to identify and address risks in the organization’s products, services, and departments.
• Review and assess risk management policies and protocols; make recommendations and implement modifications and improvements.
• Conduct product and process risk assessments.
• Monitor product and process KPIs.
• Communicate with regulatory authorities and customers when required.
• Draft and present risk reports and proposals to executive leadership and senior staff.
• Performs other duties as directed

Knowledge, Skills & Abilities:

Skills needed to be successful

• Understanding of policies and best practices of risk management (ISO 14971, ISO 31000, and ISO 27005)
• Excellent verbal and written communication skills.
• Excellent analytical and problem-solving skills.
• Excellent organizational skills and attention to detail.
• Strong team building and leadership skills.
• Proficient with Microsoft Office Suite or related software to prepare reports and policies.

• Independent and self-driven to excellence.

Required Experience & Education

• Bachelor’s degree in Risk management, Engineering, Software Engineering, or Clinical discipline with risk management experience.
• Knowledge and understanding of data protection and privacy standards: GDPR, HIPAA
• Minimum 5 years software development, medical device manufacturing, or clinical laboratory experience

Preferred Experience & Education

• Risk Management Certification
• Minimum 3 years experience in Technical Support, Design Control, Quality Assurance or Risk management within a medical device field.

Onboarding

As part of our onboarding process, all new employees will be required to attend / travel to the office on their first day of employment. This requirement is essential for onboarding activities, including the identity verification, completion of necessary documentation, receiving your IT equipment, introductions to key team members, and orientation to Clinisys policies and procedures.