Job Description:

　　Primary job responsibilities include CAPA management audit program management and Quality Management System improvements.

　　Provides oversight for the maintenance of quality programs systems processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.

　　Provides expertise and guidance in complying with policies regulatory and/or governmental regulations and internal regulations to assure compliance.

　　Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

　　Leads audit and inspection preparation resolution of audit and inspection findings and liaises with auditing groups through all stages of the audits.

　　Prepares reports and/or necessary documentation e.g. Corrective and Preventative Actions and provides to applicable stakeholders both internal and external.

　　Develop and maintain Compliance policies supporting the Risk Management program.

　　Requirements:

　　Bachelors Degree in Engineering or related degree

　　5+ years of experience

　　Expertise in CAPA, investigations, and technical writing

　　Familiar with IEC 60601 and product specific industry standards

　　Auditing experience to 21CFR820.30 21CFR820.100 ISO13485 IS0

　　Training in Risk Management ISO 14971:2012 hazard analysis and Design FMEA

　　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

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.