Complaints Engineer II – Temporary, 6 months

Role Overview

• 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 Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (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
• Assists the Team Lead or Manager to improve complaints and post market processes and procedures to generate efficiencies
• Provides support, assistance, and training for team members under guidance and direction of the Team Lead/Manager with regards to the overall complaints engineering process
• Responsible for engineering evaluation of returned products and trending analysis, in accordance with Terumo Medical Corporation procedures, and regulatory requirements
• Will interact with medical professionals, marketing, customers, customer service, clinical, regulatory, R&D and management to support in the complaint investigation process
• 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, but not limited to Food & Drug Administration (FDA), Canadian and European Union Medical Device Regulations (EU MDR) regulations governing adverse event reports such as Medical Device Reports (MDR) and Medical Device Vigilance (MDV)
• Works with the adverse event reporting group and the complaints intake group to ensure accurate, and timely generation of Medical Device Reports (MDRs) and Vigilance Reports as required
• Responsible for compilation of Post Market Safety Update Reports (PSUR) required per EU MDR for the assigned product lines or as directed by the Manager
• Ensure that the team and organizational key performance indicators and metric targets are achieved and sustained by successfully collaborating with all parts of the PMSV function and where needed, greater QA function
• Collecting timely follow up information related to complaints from customers; typically, through the 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 which includes having expert knowledge about product design, manufacturing, complaint rates, complaint trends, reportability, risk and failure modes
• Responsible for driving all complaint investigation activities with cross functional team members, prepares complaint investigation reports, conducts objective testing and product analyses on returned samples and writes customer letters
• Convenes Complaints Trending meetings per Terumo procedures, manages data and information presentation for maximum dissemination of value-added information
• Documents meeting minutes in detail and follows up on all action items and ensures their eventual closure
• Responsible for presentation of engineering failure analyses on returned complaint product at complaints trending meeting 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 a thorough complaint investigation 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
• Works independently and with different parts of the organization to resolve complex issues
• Responsible for communicating business related issues or opportunities to next management level
• Investigation and documentation of field clinical events and assist in the follow-up with Field staff
• May be required to perform customer visits to support in the investigation of critical issues and customer concerns
• Maintenance of complaint handling site procedures
• Gathers and reports various complaints metrics
• Presents critical information at Business Reviews
• Analyzes and trends Complaint data monthly to identify new and/or systemic issues as necessary
• Design and distribute data reports for management to facilitate communication and understanding of systemic issues
• Prepares responses to customers and field as necessary per process
• Stays current with all required training
• Provide engineering expertise in the installation, validation, and qualification of Complaints Investigation Test equipment which may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of the equipment
• Assists with area layouts, flow analysis and procurement of equipment
• Plan work schedules, expenditures, attend meetings, and prepare monthly reports are required
• May coordinate with Clinical Affairs in handling of clinical sample investigations

Requirements

• Requires a minimum of a 4-year degree in engineering, life sciences, or equivalent technical degree
• a minimum of three years’ experience in a medical device quality assurance or clinical environment, or equal vent 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)
• 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 individual 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

Benefits

• annual bonus
• paid vacation
• paid holidays
• health, dental and 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