Complaints Engineer II
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Job Description
Complaints Engineer investigating medical-device complaints, returned products, and adverse events for Terumo Medical Corporation. Supporting FDA, EU MDR, and global post-market surveillance compliance.
Responsibilities:
- Analyze, evaluate, and investigate complaints from external customers
- Drive complaint investigation activities with cross-functional team members
- Prepare complaint investigation reports and customer letters
- Assign and conduct testing of retention and returned samples
- Perform engineering evaluations, data analysis, additional testing, simulation testing, and root-cause investigations on returned devices
- Ensure compliance with FDA, ISO, QSR, EU MDR, and other regulatory requirements
- Support accurate and timely Medical Device Reports and Vigilance Reports
- Compile Post Market Safety Update Reports for assigned product lines
- Collect follow-up information from customers, medical professionals, field staff, Sales, Field Service, and Terumo affiliates
- Assess adverse-event reportability decisions
- Act as Post Market Surveillance subject matter expert for assigned product lines
- Convene complaint-trending meetings, present failure analyses, document minutes, and follow up on action items
- Ensure timely and complete complaint and failure investigations and closure
- Investigate and document field clinical events and potentially visit customers for critical issues
- Maintain complaint-handling site procedures
- Gather, analyze, trend, and report complaint metrics and systemic issues
- Present critical information at business reviews
- Provide engineering expertise for installation, validation, and qualification of complaint-investigation test equipment
- Assist with area layouts, flow analysis, equipment procurement, and training
- Plan work schedules and expenditures, attend meetings, and prepare monthly reports
- Provide support, assistance, and training to team members
Requirements:
- Minimum of a 4-year degree in engineering, life sciences, or equivalent technical degree and a minimum of three years’ experience in a medical device quality assurance or clinical environment, or equivalent combination of relevant education and experience
- Minimum of 4 years’ experience in a quality, customer complaint investigation/resolution, or clinical experience in medical device industry (disposable devices)
- Thorough knowledge of standards and regulations for medical devices
- Strong analytical and problem-solving skills
- Excellent written and oral English communication skills, including technical writing skills
- MS Office (Word, PowerPoint, Excel) experience
- Ability to interact with individuals and groups at all levels
- Good presentation/training skills
- Knowledge of record keeping, computer software, laboratory procedures for sample evaluation, and complaint-handling and MDR/vigilance reporting procedures
- Ability to manage multiple tasks accurately with high attention to detail
- Ability to identify priorities and function independently
- Minitab proficiency preferred
- Strongly preferred clinical experience or in-depth knowledge of interventional products and medical procedures
- ASQ Certification qualification desirable (e.g., CQE, CQIA)
Benefits:
- Annual bonus
- Paid vacation
- Paid holidays
- Health benefits
- Dental benefits
- Vision benefits
- 401(k) with matching contributions
- Tax advantage savings accounts
- Legal plan
- Voluntary life and AD&D insurance
- Voluntary long-term disability
- Short-term disability
- Critical illness and accident insurance
- Parental leave
- Personal leave
- Tuition reimbursement
- Travel assistance
- Employee assistance program
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