Terumo Aortic · 1 week ago
Senior Quality Operations Engineer
Sunrise, FL
Full-time
Onsite
Senior Level, Lead/Staff
12+ years expTerumo Aortic is a company focused on quality operations in the medical device sector. The Senior Quality Operations Engineer will support quality engineering operations, maintain regulatory compliance, and drive quality improvements while collaborating with cross-functional teams.
Health CareMedicalPersonal HealthTherapeutics
Hiring Manager
Maria Milano
Responsibilities
Participates in the nonconformance process to ensure timely completion of documentation stages
Identifies, Reports and Monitors Nonconforming events for the areas of responsibility
Performs product or process 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
Suggests, implements, reviews, and approves engineering changes to support product life cycle
Provides adequate QA support to the assigned areas and responds to Internal Audits, and takes actions as appropriate based on CAPAs, Complaint investigations, Nonconforming events, etc
Supports the Corrective and Preventive Action (CAPA) System for Quality Operations-related activities
Applies knowledge in Quality Systems to execute overall project assignments
Applies statistical tools to analyze data and identify root cause and problem resolution
Collaborates with Manufacturing, Product Support and R&D to support products for design and process improvements, and new equipment installations
Recommends decisions on administrative or operational matters and ensures Quality Assurance(s) effective achievement of objectives
Ensures quality system compliance for areas of responsibility
Serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention
Perform and lead risk assessment exercises in support of validation activities
Drive Quality Systems improvement and implementation projects
Oversees the Nonconformance process to ensure timely completion of documentation stages and drives monthly meetings
Prepare, review, execute, and summarize validation protocols (IQ, OQ, PQ)
Qualification
Required
Works with all levels within the company
Ability to organize and conduct multiple, parallel tasks
Excellent Written and Verbal Communication
Understanding of quality system regulations (ISO13485, 21CFR820)
Ability to interact with all levels within organization
Analytical skills for compiling and analyzing data
Mechanically inclined
Knowledge of DOE, SPC, Gage R&R, and sampling plans
Computer and software skills
Ability to motivate others and improve efficiency
Six Sigma Certification a plus
ASQ Quality Engineer Certification a plus
Statistics and data analysis
Bachelor's degree in a technical discipline. (Mechanical/Biomedical/Electrical engineering), or equivalent, with a minimum of 12 years of experience in medical device quality assurance
Minimum 5 years' experience in Manufacturing Engineering or Quality Engineering with preference having validation experience
Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) - ISO 13485 and ISO 14971)
Understanding of required standards / regulations impacting Medical Devices
Leadership ability and organizational skills
Strong team-oriented professional with good interpersonal skills who is hands-on with a high energy approach to work
Must have experience handling nonconforming events
Preferred
SAP knowledge is a plus
Company
Terumo Aortic
Terumo Aortic is offering services in medical and health sector.
1001-5000 employees
H1B Sponsorship
Terumo Aortic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Late StageRecent News
Google Patent
2025-05-17
Company data provided by crunchbase