Hiring: Quality Operations Manager Company: Terumo Aortic Location: Sunrise, FL Job Posted Time: 2026-09-10 11:45:34 Target Skills & Keywords : Quality Assurance, SAP About the job Experience: •Works with all levels within the company. •Strong communication skills (written and oral) •Demonstrated capacity to organize and conduct multiple, parallel tasks. •Demonstrated capacity to seek and utilize varied resources. •Understanding of medical device design and process controls per FDA Quality System Requirements (QSRs) and ISO 13485. Required Skills: •Manages Production Quality staff overseeing Receiving Inspection, Cleanroom, and Final Release areas, including all inspectors, analysts, and technicians that report into the supervisors of those areas. •Identifies, Reports and Monitors Nonconforming events for the Receiving, Cleanroom, Final Packaging and Release areas. •Performs product failure investigations and implements corrective and preventive actions to prevent reoccurrence. •Interacts with cross-functional teams to resolve quality issues. •Quality Control, product release authorizations, and quarantine of all suspect or discrepant product. •Develops Quality Instructions and Quality Standards. •Support in the development, validation, and implementation of Test Methods. •Reviews and approves engineering changes to support product life cycle. Qualifications: •Must refer to relevant company handbook/policy statements detailing company procedures regarding employee conditions and benefits. •Authorization of purchase orders is given in Authorization of Limits produced by Finance Department •Ensure compliance with all quality systems regulatory requirements such as, but not limited to, ISO 13485, 21 CFR Part 820, MDSAP, MDD (93/42/EEC) and MDR (EU 2017/745) •Lead and oversee addressing issues within the QMS without undue delay as evidenced by on time completion of actions on the Single Action Tracker (SAT) •Create a safety culture and safe working environment. •Ensure compliance with all Environmental Health and Safety regulatory requirements. •Provide recourse to meet Environmental Health and Safety goals. •Maintain defined organization Environmental Health and Safety competencies. •Ensure related Risk Assessments are completed, accidents raised and action hazards. •A bachelor’s degree or equivalent experience in Engineering, Quality Engineering or Sciences. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!