Provides overall management of the CAPA process for the site. Leads the CAPA review activities..
Responsible for implementing and maintaining the effectiveness of the CAPA elements of the quality system.
Support the site maintain compliance and complete CAPAs timely and effectively.
Ensures systems are established, effective and maintained in compliance with regulatory, corporate and site requirements and policies related to CAPA
Identifies, leads and implements initiatives for the continual improvement of the CAPA processes.
Develops, implements, monitors and maintains meaningful metrics to demonstrate the effectiveness of the Supplier Management and CAPA processes.
Prepares audit responses and monitors and reports status of audit response progress to management.
Provides support to the supplier management process and determines appropriate actions to maintain compliant system. Supports the annual audit plans and utilizes internal and external resources to accomplish plan.
Thorough understanding of ISO/QSRs and the ability to apply the knowledge to the business to ensure compliance to the regulations
Provide support to the supplier CAR process, issues SCARs and approves corrective and preventive actions. Creates supplier development plans as necessary and monitors development for effectiveness.
Support, and hosts audit team for on-site inspections and audits by customers, and regulatory agencies.
Report metrics and provide input to management reviews where CAPA issues are discussed advising management of potential risks and make recommendations.
Travel is required – approximately 20%
B.A., B.S. or M.S. in Life Sciences or an engineering discipline or an equivalent combination of education, experience and/or licensure/certification.
Prior experience in a leadership capacity preferred
The required skills, knowledge and abilities that are typically acquired through a minimum of 5 years medical device, pharmaceutical or food industry experience in quality assurance.
Knowledge of overall regulatory requirements associated with medical products into worldwide markets.
Must have experience and knowledge of ISO 13485, 21 CFR Part 820, IVD Directive and Canadian MDR.
Communicate effectively both verbally and written with supplier and internal personnel in a professional manner. Strong writing and facilitation skills. Function with little to no supervision.
Demonstrated ability to work effectively in teams.
Detail oriented and has the ability to lead multiple projects and activities assigned.
Must have demonstrated hands on, results oriented, multi-tasking response to the urgent needs of the company and show a strong track record of meeting deadlines.