Responsibilities:

　　Develop and maintain risk management files and pFMEAs for new processes and process changes.

　　Support validations for new and existing products, processes and equipment.

　　Manage NC/CAPA teams through identification and development of corrective action plans, verification and closure.

　　Coordinate and support supplier quality management activities, including qualification and evaluation, supplier investigations, etc…

　　Manage and support batch record review and disposition of product.

　　Support and prepare for site-level internal, external, supplier and customer audits.

　　Apply systematic problem-solving methodologies and provide quality support to identify and resolve quality issues to ensure production of safe and effective medical devices.

　　Identify and implement opportunities for continuous improvement.

　　Interact and coordinate activities with other departments, external vendors and customers.

　　Perform other Quality System related duties as required.

　　  Qualifications:

　　Bachelors degree required, preferably in Engineering, Science (Chemistry, Biology, Physics, etc) or Math (Statistics).

　　Experience in an FDA regulated manufacturing or industrial environment.

　　Strong working knowledge of FDA / ISO 13485 Quality System. requirements, GxP, and other relevant standards and regulations.

　　Technical skills and experience related to process validation, statistical methods, and risk management.

　　Experience performing quality audits. Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) preferred.

　　Lean manufacturing / Six Sigma helpul

　　Strong cross-collaborator, effective coaching and mentoring skills

　　Ability to work independently, well organized and self-driven.

　　Excellent written and verbal communication skills.

　　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.