Complaints Engineer II

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Analyze, assess, and investigate complaints from external customers.

• Lead complaint investigation efforts alongside cross-functional team members.

• Create investigation reports and customer correspondence related to complaints.

• Assign and perform testing on retention and returned samples.

• Conduct engineering evaluations, analyze data, perform additional testing, carry out simulation testing, and investigate root causes on returned devices.

• Ensure adherence to FDA, ISO, QSR, EU MDR, and other regulatory standards.

• Assist in the preparation of accurate and timely Medical Device Reports and Vigilance Reports.

• Compile Post Market Safety Update Reports for designated product lines.

• Gather follow-up information from customers, healthcare professionals, field staff, Sales, Field Service, and Terumo affiliates.

• Evaluate decisions regarding adverse-event reportability.

• Serve as the subject matter expert for Post Market Surveillance for assigned product lines.

• Organize complaint-trending meetings, present failure analyses, document minutes, and follow up on action items.

• Ensure that complaint and failure investigations are conducted in a timely and thorough manner, leading to closure.

• Investigate and document field clinical events, potentially visiting customers for urgent issues.

• Maintain procedures for complaint handling at the site level.

• Collect, analyze, trend, and report on complaint metrics and systemic issues.

• Present essential information during business reviews.

• Provide engineering expertise for the installation, validation, and qualification of equipment used in complaint investigations.

• Assist with layout planning, flow analysis, equipment procurement, and training initiatives.

• Organize work schedules and budgets, attend meetings, and prepare monthly reports.

• Offer support, assistance, and training to team members.

⛳️ Requirements

• A minimum of a 4-year degree in engineering, life sciences, or a related technical field, along with at least three years of experience in a medical device quality assurance or clinical setting, or a comparable combination of relevant education and experience.

• At least four years of experience in quality, customer complaint investigation/resolution, or clinical roles within the medical device sector (specifically disposable devices).

• Comprehensive knowledge of standards and regulations governing medical devices.

• Strong analytical and problem-solving abilities.

• Exceptional written and verbal communication skills in English, including technical writing expertise.

• Proficiency in MS Office applications (Word, PowerPoint, Excel).

• Capability to engage with individuals and groups at all organizational levels.

• Effective presentation and training abilities.

• Familiarity with record-keeping practices, computer software, laboratory procedures for sample evaluation, and complaint handling and MDR/vigilance reporting protocols.

• Ability to manage multiple tasks accurately while maintaining high attention to detail.

• Skill in prioritizing tasks and functioning independently.

• Proficiency in Minitab is preferred.

• Strongly preferred experience in clinical settings or extensive knowledge of interventional products and medical procedures.

• ASQ Certification (e.g., CQE, CQIA) is desirable.

🏝️ Benefits

• Annual bonus.

• Paid vacation.

• Paid holidays.

• Health benefits.

• Dental benefits.

• Vision benefits.

• 401(k) with matching contributions.

• Tax-advantaged 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.