Product Complaint Manager

4 weeks ago

Manchester, New Hampshire, United States DEKA Research & Development Full time
Job Overview

DEKA Research and Development is seeking a highly skilled Product Complaint Manager to join our team. As a key member of our Medical Device Research and Development environment, you will play a critical role in ensuring regulatory compliance and customer satisfaction.

Key Responsibilities
  • Manage a diverse team of Complaints Specialists, providing guidance and individual coaching as needed
  • Develop and maintain product complaint and Adverse Event intake training, job aids, and reference documents
  • Interpret and ensure proper classification and completeness of complaints before closure
  • Escalate reports of potentially serious product issues to senior management
  • Monitor the product complaint mailbox and perform daily review, evaluation, and corrections on complaint records
  • Ensure routine deliverables to customers are accurate and on-time
  • Process cases in compliance with local procedures and regulations
  • Act as Subject Matter Expert and provide support during audits
  • Understand and apply knowledge of relevant regulations to ensure accurate and timely complaint handling
Requirements
  • Preferred bachelor's degree with 5+ years experience in post-market surveillance/complaint handling in a regulated environment; management and medical device experience preferred
  • Strong communication and detail-oriented skills, with the ability to communicate complex issues to resolve issues and mitigate risks
  • Strong organizational and prioritization skills, with a customer service-oriented approach
  • Experience working with all levels of management and the ability to influence
  • Ability to manage multiple projects in a fast-paced environment
  • Excellent interpersonal skills, with experience developing important relationships with key stakeholders
  • Excellent analytical skills and proficiency in Office suite programs
  • Ability to apply product complaint knowledge to make sound judgment calls and drive continuous improvements

About DEKA Research and Development:

DEKA Research and Development is a dynamic and innovative company that strives to make a difference every day through thoughtful engineering, design, and manufacturing. We are committed to creating life-changing products and welcome new ideas and approaches.

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