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Responsibilities:

• Champion processes within our Quality System in collaboration with SMEs, Divisional Process Owners, and the Corporate Quality System.
• Establish and maintain QMS processes that meet regulatory and standards requirements while maximizing business process outcomes that drive efficiency and compliance
• Serve as a process owner of one or more Quality Management Systems processes such as Internal Audit, Nonconformance and CAPA, Training, Record Retention, Quality System Documents Change Management, or Quality Agreements.
• Work closely with Divisional Process Owners and SMEs in the creation or updating of our quality systems content while maintaining compliance to our quality system.
• Build understanding of quality concepts and drive improvements in support of changing regulations/requirements of our quality system content and processes.
• Collaborate with SMEs and management to drive an engaged process to meet performance metrics or drive process improvements.
• Support data analysis to identify or lead quality improvements of our products, systems, or processes.
• Participate in internal compliance audits FDA, ISO, and Internal Audits
• Support external audits as an SME of your QMS process areas of responsibility
• Monitor and drive KPIs to maintain and support effective process outcomes.
• Business Unit Highlights Deliver or support the Monthly/Regular recurring data analysis and trending to support the Quality Plan.

Requirements:

• Bachelor's degree in science or related discipline.
• Minimum of 2+ years' experience in regulated environment
• Knowledge and understanding of US and International Medical Device Regulations highly preferred
• Knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.) highly preferred