sterilization quality assurance engineer.

Responsible to overview all the sterilization processes executed by the manufactuing site or the qualified subcontractors.
Review and approve sterilization validation/requalification activities including equipment validation/qualifications (IQ, OQ and PQ).
Follow up and support routine sterilization activities.
Ensure requalification activities related to medical devices and combination products are performed on a timelly manner.
Review/approve product and process change control documentation and specifications,provide required inputs from sterilization process perspective.
Ensure compliant implementation of the process/product chnages from sterilization eperspective.
Coordination of sterilization qualification and requalification activities with sterilization vendors and sterilization operation team.
Collaborating with team members and overseeing external partners (contact sterilizers,testing labs, etc) to achieve process/project objectives.
Reviewing and evaluating process issues, performing root cause analyses in case nonconformitieshappen and implementing process improvements.
Applying Engineering/Scientific/GMP theories, principles techniques to solve problems.
Responsible for providing engineering support and ensuring quality compliance in accordance with documented procedures for all aspects of functional responsibility.