Role Overview :
This position will implement the quality activities necessary to move a product line from internal manufacturing to a contract manufacturer and merge the requirements necessary as a legal manufacturer of the product into an existing quality system.
This involves quality system updates, procedure generation, training, and technical support. The Quality Engineer determines methods, techniques, and evaluation criteria for medical devices.
He / she serves as a key resource for ISO, US FDA, and QSR requirements.
40%) Plan and implement the updates necessary to ensure the Quality System of the new legal manufacturer meets all requirements associated with a combination production (medical device and drug).
Ensure compliance to product specific standards, QSR, US FDA, ISO, IEC, and UL requirements. Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System.
35%) Provide quality leadership to project teams as the quality engineering representative. Work with a team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications / standards and that the safety and reliability of products are established.
Generate / approve / manage sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.
10%) Support establishing contract manufacturer operations and provide expertise in product requirements, risk management, test methods, and statistical analysis.
10%) Work with outside labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier.
5%) Support Management Review and audits / inspections.
Education Requirements :
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