Manage supplier quality performance, investigate supplier-related quality issues, and drive corrective actions and continuous improvement for regulated medical device products. Job Requirements Bachelor's degree in Engineering. 4+ years of Supplier Quality Engineering or related quality engineering experience. Experience in medical device or other regulated manufacturing environments. Experience with supplier quality management and supplier performance monitoring. Experience investigating supplier-related quality issues. Experience with Supplier Corrective Action Requests (SCARs). Experience owning or supporting Corrective and Preventive Actions (CAPA). Experience performing root cause analysis. Knowledge of quality management systems and regulatory compliance requirements. Experience driving supplier development and quality improvement activities. Ability to work 100% onsite. Preferred Skills Experience supporting cardiac surgery or cardiovascular medical devices. Experience with cannulae, heart positioners, or related surgical products. Experience managing quality across a large supplier or product portfolio. Experience supporting supplier audits and supplier qualification activities. Experience analyzing supplier quality metrics, trends, and nonconformance data. Experience working with engineering, operations, manufacturing, and supplier quality teams. Job Responsibilities Monitor supplier quality performance and identify adverse quality trends. Investigate supplier-related nonconformances and product quality issues. Issue, manage, and follow up on Supplier Corrective Action Requests. Perform root cause analysis for supplier quality issues. Develop, review, and verify corrective and preventive actions. Support CAPA activities associated with supplier and component quality. Drive supplier development and continuous improvement initiatives. Evaluate supplier quality data and performance metrics. Support supplier qualification, evaluation, and ongoing performance monitoring. Work with suppliers to improve component quality, manufacturing processes, and compliance. Partner with engineering and operations teams to resolve supplier-related technical issues. Maintain supplier quality documentation and records in accordance with applicable quality system requirements. Support quality and regulatory compliance activities for medical device manufacturing. Evaluate effectiveness of implemented corrective actions and supplier improvements. Support quality initiatives for cardiac surgery products and associated components.

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.