This role serves as a strategic partner to Quality, ensuring medical device testing, laboratory compliance, technical excellence, and continuous improvement across regional laboratory operations. The position will develop and lead a team of Scientific Analysts with a strong focus on compliance to ISO 17025 and applicable medical device testing standards. The role is responsible for supporting medical device laboratory process audits, technical assessments, proficiency testing programs and driving appropriate corrective actions. It evaluates medical device testing standards across regional laboratories, identifies gaps, and ensures timely closure through collaboration with the global technical team, laboratory operations and cross-functional stakeholders.
A key aspect of the role includes monitoring and trending critical quality indicators such as out-of-specification results (OOS), nonconformances (NCs), change controls (CCs), deviations, and CAPAs. The position drives data-based insights and improvement initiatives in partnership with Lab Operations and quality.
The role also contributes to global harmonization initiatives, supports Customer and regulatory audits, and facilitates onboarding of new analytical technologies and services.
The position acts as a technical escalation point, supports Customer discussions, and represents the organization through external presentations and knowledge-sharing forums. It also plays a critical role in developing team capabilities by promoting technical growth, establishing best practices for medical device bioburden, sterility and endotoxin method design and validation, and leading development programs such as trade-a-tech and technical learning initiatives.
Overall, this position is pivotal in strengthening compliance, enhancing technical capabilities, improving Customer experience, and driving a culture of continuous learning and operational excellence across the laboratory network.
