Manager, Quality Assurance
CooperVision
- Tucson, AZ
- Permanent
- Full-time
- Responsible for day to day oversight of the following Quality System Components:
- Quality Events (Deviations, Nonconformance, Change Control)
- CAPA o Complaint handling and resolution
- Supplier Quality
- Document Control
- Records Management o Document Training
- Maintains a culture of quality awareness, teamwork, and cooperation with Quality customers.
- Lead the implementation of a robust Quality System that will ensure premium patient care delivering internal and external customer satisfaction.
- Manage and coordinates all aspects of quality working at all levels of the organization as necessary to implement policies and procedures necessary for quality requirements.
- Represent and own quality corporate functions including, but not limited to: Management Review, Core Team member on projects and inspections (internal and external)
- Assists in implementation of regulatory changes impacting quality systems and support for quality.
- Establish and implement consistent metrics for monitoring system effectiveness to enable Quality customers to make sound quality decisions and drive continuous improvement.
- Clearly communicate quality issues, identified risks, continuous improvements opportunities and corrective actions throughout affected departments and leadership teams
- Performing compliance review and approval on executed records for completeness of all required testing, verification of documents for various processes
- Perform other Quality Assurance tasks as required.
- Hybrid (3-4 days a week onsite)
- Lead and coach individuals within the Quality Team. Conduct ongoing performance acceleration/ evaluation assessment and provide feedback to employees in order to help optimize their and the teams overall performance
- Mentor the team and actively identifies professional development opportunities
- Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
- Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Proactively mentor and provide resource for personnel professional development.
- Bachelor's Degree in Science or a related discipline and five to seven years related experience and/or training or Associates degree (A.A.) with eight to ten years related experience and/or training; or equivalent combination of education and experience.
- Candidate should demonstrate knowledge of regulations and standards such as:
- CLIA (42 CFR 493), FDA (21 CFR 820); Industry standards: ISO 15189 Medical Laboratories
- AABB, FDA (HCT/P, cGMP, cGTP), 21CFR1271 and ISO regulations
- Identifies ways to improve processes/situations Job Description
- Takes responsibility for improvements or solving problems.
- Must display eagerness to learn and continuously improve.
- Sets own standards above prevailing standards, shows dissatisfaction with substandard or inefficient activities Interpersonal Skills
- Socially capable - interacts confidently, reads the situation
- Empathetic and can evaluate likely reactions
- Collaborative approach