[Hiring] Complaints Engineer II @Terumo

Role Description

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.
• Prepares complaint investigation reports, assigns test on retention, and returned samples.
• 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.
• Responsible for engineering evaluation of returned products and trending analysis.
• Interacts with medical professionals, marketing, customers, customer service, clinical, regulatory, R&D and management to support in the complaint investigation process.

Qualifications

• 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.
• Ability 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.

Requirements

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

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.