Complaints Engineer II, Temporary, Remote

Job Summary

The Complaints Engineer II is responsible for analyses, evaluation and product investigation of complaints received from external customers with respect to business objectives and in compliance with FDA, ISO, QSR, EU MDR, and other regulatory guidelines. Drives all complaint investigation activities with cross functional team members and prepares complaint investigation reports, assigns test on retention and returned samples, and writes customer letters.

Job Details

• Promotes a work environment of continuous improvement that supports Terumo Quality Policy, Quality System, and the appropriate regulations.
• Accountable for compliance with applicable US and International regulations and directives, including FDA, Canadian and EU MDR regulations governing adverse event reports such as MDR and MDV.
• Works with the adverse event reporting group and the complaints intake group to ensure accurate and timely generation of Medical Device Reports and Vigilance Reports.
• Responsible for compilation of Post Market Safety Update Reports (PSUR) required per EU MDR for assigned product lines.
• Ensure team and organizational key performance indicators and metric targets are achieved and sustained.
• Collect timely follow up information related to complaints from customers, typically through Sales and/or Field Service groups.
• Collaborate in assessing Adverse Event Reportability decisions in accordance with US and International regulations.
• Act as Post Market Surveillance Subject Matter Expert for assigned product lines, including expert knowledge about product design, manufacturing, complaint rates, complaint trends, reportability, risk and failure modes.
• Drive all complaint investigation activities with cross functional team members, prepare complaint investigation reports, conduct objective testing and product analyses on returned samples, and write customer letters.
• Convene Complaints Trending meetings per Terumo procedures, manage data and information presentation, document meeting minutes, and follow up on all action items.
• Present engineering failure analyses on returned complaint product at complaints trending meetings and other forums.
• Perform retention, decontamination and testing of returned devices.
• Perform data analysis, additional testing, simulation testing, and root cause investigations and resolution in support of thorough complaint investigations related to product quality and patient safety.
• Ensure timely, accurate and complete complaints and failure investigations of returned products.
• Ensure timely closure of complaints to comply with FDA requirements and other regulatory bodies and countries.
• Work independently and with different parts of the organization to resolve complex issues.
• Communicate business related issues or opportunities to next management level.
• Investigate and document field clinical events and assist in follow-up with Field staff.
• May perform customer visits to support investigation of critical issues and customer concerns.
• Maintain complaint handling site procedures.
• Gather and report various complaints metrics and present critical information at Business Reviews.
• Analyze and trend Complaint data monthly to identify new and/or systemic issues.
• Design and distribute data reports for management to facilitate communication and understanding of systemic issues.
• Prepare responses to customers and field as necessary per process.
• Stay current with all required training.
• Provide engineering expertise in the installation, validation, and qualification of Complaints Investigation Test equipment, including feasibility studies and documentation for justification of project and training.
• Assist with area layouts, flow analysis and procurement of equipment.
• Plan work schedules, expenditures, attend meetings, and prepare monthly reports.
• May coordinate with Clinical Affairs in handling of clinical sample investigations.

Position Requirements

• Thorough knowledge of standards and regulations for medical devices.
• Strong analytical and problem-solving skills.
• Excellent written and oral English communication skills required, including technical writing skills.
• MS Office (Word, PowerPoint, Excel) experience required.
• Ability to interact with individuals and groups at all levels.
• Good presentation/training skills required.
• Knowledge in record keeping, computer software, laboratory procedures used for evaluation of samples, and procedures related to Complaint-Handling and MDR/vigilance reporting in accordance with all applicable regulations.
• Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
• Ability to identify priorities and function independently required.
• Minitab proficiency is preferred.
• Requires a 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).
• Strongly prefer Clinical Experience or in-depth knowledge of interventional products & medical procedures.
• ASQ Certification qualification desirable (e.g. CQE, CQIA).