Complaints Engineer II

🔥 12 hours ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $34 - $48 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

👷🏻‍♀️ Engineer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Terumo Medical Corporation

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1972

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Terumo Medical Corporation is a leading provider of high-quality medical devices and solutions focused on improving patient care and enhancing healthcare outcomes. With a commitment to innovation and a collaborative work environment, Terumo values its associates as essential assets and offers them rewarding career paths and opportunities for professional growth. The company actively engages in community support and fosters a culture of teamwork and lifelong learning among its employees.

📋 Description

• 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