Product Complaint Manager - DEKA Research & Development

DEKA R&D has an immediate opening for a Product Complaint Manager to work in a dynamic Medical Device Research and Development environment.  The position reports to the Program Manager. This is a high visibility role with a significant impact to regulatory compliance and customer satisfaction.

How you will make an impact:

• Manages a diverse team of Complaints Specialists, monitors the performance of the team, and provides guidance and individual coaching as needed
• Conducts, maintains, and creates product complaint and Adverse Event intake training, job aids, refresher slide decks and reference documents to ensure the Complaints Specialists respond to and process technical product complaints
• Understands complexity of complaints to interpret and ensure proper classification and completeness before closure
• Escalates reports of potentially serious product issues to senior management
• Monitors the product complaint mailbox and performs daily review, evaluation, corrections on complaint records. Resolves day-to-day inaccuracies and issues
• Ensures routine deliverables to customers are accurate and on-time
• Obtains all relevant information and creates complaint record within database
• Processes cases in compliance with local procedures and regulations
• Acts as Subject Matter Expert and otherwise provides support during audits
• Understands appropriate regulations; applies knowledge to ensure accurate and timely complaint handling
• Provides backup coverage for day-to-day activities
• Performs other related duties as assigned under management supervision

Skills needed to be successful:

• Preferred bachelor’s degree with 5 years experience in post market surveillance/ complaint handling in a regulated environment; management and medical device experience preferred. Additional experience and training considered in lieu of degree
• Strong communication skills and detail oriented both oral and written, as well as an ability to communicate complex issues to resolve issues and mitigate risks
• Strong organizational and prioritization skills, customer service oriented
• Experience working with all levels of management and an ability to influence
• Ability to manage multiple projects in a very fast-paced environment
• Excellent interpersonal skills; experience developing important relationships with key stakeholders, refined conflict management and negotiation skills
• Excellent analytical skills and proficiency in Office suite programs
• Ability to apply product complaint (and adverse event) knowledge to make sound judgment calls and drives continuous improvements
• Experience with TrackWise preferred

About DEKA:

One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.

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