Job Description

Managing the Site Quality Management System, fully integrated into the Cytiva Quality Management System, including cross-functional and site-specific processes. The role has a responsibility for facility compliance covering all quality requirements

• Maintaining and improving all aspects of Site Quality Planning.
• Participating in all Quality-related communications and training requirements for all site employees.
• Establishing positive relationships with outside agencies.
• Participating in site audit readiness and hosting Quality System audits and inspections.
• Overseeing the Corrective Action / Preventive Action activities and Complaint Handling Programs, and in some cases, Quality Engineering.
• Report on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews.
• Driving the definition of site quality objectives, metrics, reporting and operating mechanisms.
• Participating in selected global initiatives to share best practices and leverage quality synergies.
• Supporting local R&D programs and quality issue resolution.

Required Knowledge, Skills, and Abilities

Bachelor's degree in Engineering, Medical Device Technology or Scientific Field (or High School diploma/GED and a minimum of 8 years work experience. Minimum 4 years professional experience and understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry. Minimum 3 years supervisory/ management experience, including hiring, training, coaching and performance management activities. Experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements. Proven track record in performing external and internal audits with preferably a Professional certification as a Lead Auditor. Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations. Effective report, business correspondence and procedure writing skills. Good problem identification, multivariable analysis and creative resolution aptitude. Proven process development and project management skills. Strong computer skills. Ability to communicate using English.