Back to jobsParticipate in complex medical device design and development projects, collaborating across functional areas to support and drive project deliverables to completion
Support design and specifications for inspection and testing plans/procedures/systems to ensure products conform to specifications and quality standards.
Support the implementation of possible solutions/improvements, utilize the Corrective and Preventive Action (CAPA) system.
Review, and approve disposition for nonconforming product.
Review Change Orders, Deviation Authorizations, Verification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures.
Support efforts to continuously improve quality management systems and product quality, while ensuring safety, efficacy and regulatory compliance.
Support all functional departments to ensure compliance with Quality System and lead continuous improvement efforts of the Quality System.
Represent Quality Assurance on product development teams, including developing Quality Plans and Risk Management Plans.
Provide input for quality management review.
Support customer audits and assist as needed with external audits such as FDA and ISO.
May Investigate/analyze customer complaints and support Regulatory Affairs to monitor customer complaint trends and maintain compliance to complaint system.
Maintain a positive demeanor while interacting with personnel from all areas of Medevio to foster improved quality and reduced cost.
Promote a quality culture by clearly communicating the importance of adherence to procedure, providing rationale and context behind decisions, and seeking out areas for continuous improvement.
Ensure documentation accuracy and completeness of product and process development activities.
Other duties assigned as required.
