• Product Complaints Specialist

    DEKA Research & Development (Manchester, NH)


    DEKA R&D has an immediate opening for a Product Complaints Specialist to work in a dynamic Medical Device Research and Development environment.  The position reports to the Product Complaints Manager.  This is a role with direct impact to the Quality Management System.

    How you will make an impact:

    + Responsible for reviewing and entering complaint information related to potential medical device issues.

    + Generate requests for additional information to complete complaint evaluations.

    + Perform product complaint evaluations independently while also collaborating with other team members.

    + Ensure that complaint documentation follows Good Documentation Practices; meets QMS requirements; and complies with U.S. Food and Drug Administration (FDA) regulations / other regulatory requirements.

    + Interface with Third Party Manufacturers, health care professionals, internal customers, and regulatory agencies.

    + Influence the creation of new procedures and work instructions.

    + Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors.

    + Perform other related duties as assigned under management supervision.

    Skills needed to be successful:

    + 1+ year(s) work experience in a cGMP related industry or in a clinical setting is preferred.

    + Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211)

    + Experience with SalesForce is preferred.

    + Strong motivation to see individual tasks through to completion, and to help as needed to achieve team goals.

    + Exceptional time management skills with the ability to prioritize multiple projects and ensure compliance with regulations and standard operating procedures.

    + Good problem-solving and proficient computer skills are required.

    + Solid written/verbal communication and organizational skills, as well as attention to detail.

    + Sound technical writing skills.

    + Ability to work well independently and on cross-functional teams in a fast-paced, changing environment.

    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 & 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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