This position will implement, support, and sustain elements of Smith & Nephew's Quality System through procedure generation, training, auditing, and technical support. The Quality Engineer determines methods, techniques, and evaluation criteria for medical devices. He/she serves as a key resource for ISO, EN, MDD, and QSR requirements.
* Provide quality leadership to sustaining 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 design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation. * Support manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis. * Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD requirements. Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System. * Work with outside labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier. * Support continuous improvement activities (CCRs and/or PARs). * Support Post Market Surveillance activities, Management Review, and audits/inspections.
Travel: 5% international & domestic travel expected
Education: Bachelor's degree in engineering or related discipline
Experience: 1-6 years in the medical device or related industry
* Need to be able to make sound decisions with attention to details * Understanding the impact of regulatory requirements (eg. GMP's, ISO 13485, ISO 14971, and MDD) on Smith & Nephew's products is necessary * Must be able to provide and implement solutions to quality problems * Ability to plan and schedule multiple projects and tasks * Effective written/oral communication skills * Team player * MS Office, MS Excel, and Statistical software proficiency
* Weight Lifting: Light (0kg - 5kg) * Position: Mostly sitting * Repetitive Motion: Mostly computer use * Chemical Exposure: No chemicals exposure or cleaning use only * Physical Risk (Personal Protective Equipment - PPE): Occasional use of PPE required