Complaints Engineer II, Temporary, Remote

Terumo•Elkton, MD

3d•$34 - $48•Remote

About The Position

The Complaints Engineer II analyzes, evaluates, and investigates complaints received from external customers, ensuring compliance with applicable FDA, ISO, QSR, EU MDR, and other regulatory requirements. The role drives cross-functional complaint investigations, evaluates returned products, conducts testing and root-cause analysis, prepares investigation reports and customer communications, and supports complaint and post-market process improvements. The position supports complaint handling and adverse-event reporting, including Medical Device Reports, vigilance reports, and Post Market Safety Update Reports for assigned product lines. It collaborates with customers, medical professionals, sales and field service staff, and internal teams across clinical, regulatory, R&D, marketing, customer service, and management. The engineer also analyzes complaint trends and metrics, presents findings, coordinates trending meetings and action-item follow-up, and maintains complaint-handling procedures. The role provides engineering expertise related to complaint investigation equipment, including installation, validation, and qualification, and may support customer visits for critical investigations and clinical sample investigations. This is a temporary, remote position. The listed hourly rate is $34–$48.

Requirements

A minimum four-year degree in engineering, life sciences, or an equivalent technical field, and at least three years of experience in medical-device quality assurance or a clinical environment, or an equivalent combination of relevant education and experience.
At least four years of experience in quality, customer complaint investigation/resolution, or clinical work in the medical-device industry involving disposable devices.
Thorough knowledge of medical-device standards and regulations.
Strong analytical and problem-solving skills.
Excellent written and oral English communication skills, including technical writing.
Experience with Microsoft Word, PowerPoint, and Excel.
Ability to interact with individuals and groups at all levels.
Good presentation and training skills.
Knowledge of record keeping, computer software, laboratory procedures for evaluating samples, and complaint-handling and MDR/vigilance reporting procedures under applicable regulations.
Ability to manage multiple tasks accurately and with strong attention to detail.
Ability to identify priorities and work independently.

Nice To Haves

Minitab proficiency.
Clinical experience or in-depth knowledge of interventional products and medical procedures.
ASQ certification qualification, such as CQE or CQIA.

Responsibilities

Promote continuous improvement in support of Terumo’s Quality Policy, Quality System, and applicable regulations.
Ensure compliance with applicable US and international medical-device regulations and directives, including requirements for adverse-event reporting.
Coordinate with adverse-event reporting and complaint-intake groups to support accurate and timely MDR and vigilance report generation.
Compile EU MDR Post Market Safety Update Reports for assigned product lines or as directed by the Manager.
Collaborate across the PMSV and QA functions to achieve and sustain organizational performance indicators and metric targets.
Collect timely complaint follow-up information from customers and relevant stakeholders, including sales, field service, medical professionals, field staff, and Terumo affiliates.
Collaborate on adverse-event reportability assessments under US and international regulations.
Serve as a post-market surveillance subject matter expert for assigned product lines, including product design, manufacturing, complaint trends, reportability, risk, and failure modes.
Drive cross-functional complaint investigations; prepare investigation reports, conduct objective testing and returned-product analyses, and write customer letters.
Convene complaint trending meetings, present data and information, document meeting minutes, and follow up on action items through closure.
Present engineering failure analyses of returned complaint products at trending meetings and other forums.
Perform retention, decontamination, and testing of returned devices; conduct data analysis, additional and simulation testing, root-cause investigations, and resolution activities.
Ensure complaint and failure investigations are timely, accurate, complete, and closed in accordance with regulatory requirements.
Work independently and cross-functionally to resolve complex issues, and communicate business issues or opportunities to the next management level.
Investigate and document field clinical events and assist with follow-up by field staff; customer visits may be required for critical issues and concerns.
Maintain complaint-handling site procedures.
Gather, report, analyze, and trend complaint metrics; present critical information at business reviews and distribute reports to management.
Prepare responses to customers and field personnel as required by process.
Stay current with required training.
Provide engineering expertise for installation, validation, and qualification of complaint-investigation test equipment, including feasibility studies, project justification documentation, and user training; assist with area layouts, flow analysis, and equipment procurement.
Plan work schedules and expenditures, attend meetings, and prepare monthly reports.
Coordinate with Clinical Affairs on clinical sample investigations when needed.
Provide support, assistance, and training to team members under the guidance of the Team Lead or Manager.