Description:

　　Conducts compliance audits of complex documentation and data.

　　Serves as QA interface to other departments and/or partners. Manage, mentor, and train staff in our quality system procedures, and the general regulatory compliance requirements associated with in-vitro diagnostic medical devices.

　　Review quality outputs for compliance to internal and external requirements (21 CFR 820, ISO 13485, ISO 14971,MDSAP, etc.).

　　Assist in chairing meetings as appropriate, including preparing appropriate agendas and meeting minutes with limited supervision. Monitors progress of such meeting agendas and reports progress as appropriate.

　　Develops, maintains, and reports department metrics as needed.

　　Serves as QA interface for design projects, ensuring compliance with applicable domestic and international standards and meeting project timelines.

　　Review and assess appropriateness of document changes in accordance with internal procedures.

　　Contributor to CAPA and NCR System. This includes reviewing adequacy of root cause, corrections, corrective actions, preventive actions, and effectiveness. In addition to reviewing CAPA records, owning CAPA records where appropriate.

　　Develop, implement, and maintain quality system processes from a site level perspective.

　　Review and assess change control, validation and qualification documents.

　　Assist and own applicable portions of supplier management system, complaint system and design control.

　　Assist in external and regulatory body audits.

　　Skills:

　　Quality assurance, corrective action plans, change control, Quality control, Capa, Audit, Batch record review

　　Additional Skills & Qualifications:

　　Quality Assurance

　　13485

　　CAPA

　　NCR

　　RCA

　　Experience Level:

　　Intermediate Level

　　About Actalent

　　Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

　　If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.