TM QC Test Lead

The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role As we continue to grow as QuidelOrtho, we are seeking a Senior Manager, TM Testing. The Senior Manager, TM Testing will prioritize and schedule work to meet business needs. They will control and deploy resources appropriately and highlight areas of concern. They will be the lead decision maker escalating issues to the Senior Manager, TM Testing as appropriate. Able to deputize and support other groups in the Quality team when required. Accountable for the delivery of the production plan within frameworks of health, safety, quality, compliance and environmental policies acting as focus for communication for other work areas. Responsible for monitoring and analysis of appropriate metrics to determine efficiency and effectiveness of groups outputs. Takes the lead in daily departmental meetings, presenting metrics and working closely with support functions. This position is in Pompano Beach Florida. The Responsibilities Provide the leadership and training required to achieve empowered and motivated teams with effective co-operation within and between teams. Full oversight of all aspects of people management to include performance management, mentoring, coaching and development. Setting goals to meet short and medium term business needs. Appropriately manages skills and resources within the area to ensure the ongoing development of the team members and identification of skills gaps. Operates in line with company quality standards such as ISO9001 and appropriate regulatory authorities such as US FDA or TUV and ensures team members are compliant with these standards. Ensures department is always in 'audit ready state' and leads preparation activities for department in readiness for audits by external bodies. Takes responsibility for ensuring all employees have up to date job descriptions, training plans & records. Controls and monitors spend against AOP with an understanding of budget setting. Ensures adherence to AOP for any agreed capital investment. Participates in the setting and tracking of AOP. Identification and implementation of initiatives resulting in productivity gains Recruits to fill open positions in timely manner, considering future growth & needs of department group and pipeline for key roles Perform other work-related duties as assigned. The Individual Required Degree qualification in a science, engineering or related technical discipline. 3+ years in a Quality or Compliance role in the medical device or diagnostic sector. Proven ability to lead and develop high-performing teams. Strong PC literacy including full MS Office Suite. Strong collaboration, influence and communication skills across functional and organizational boundaries. Ability to carry out structured problem solving, knowledge of lean and process excellence tools. Preferred Experience supporting global regulatory inspections. Strong understanding of Quality of Quality System regulations and standards, including

ISO 13485, FDA 21

CFR80 and IVDR.

The Key Working Interactions Internal:

Operations, Supply Chain, R D, Regulatory Affairs, Technical Support and other Quality and Compliance teams globally and regionally

External:

Notified Bodies. The Work Environment The work environment characteristics are representative of an office, laboratory and manufacturing environment. The Physical Demands No strenuous physical activity. Standard activities include sitting, standing, walking, talking, hearing, and visual work. Equal Employment Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.