Complaints Specialist
DEKA Research & Development
DEKA R&D has an immediate opening for a Complaints Specialist to work in a dynamic Medical Device Research and Development environment. The Complaints Specialist position reports to the Product Complaints Manager and will be part of a growing team. This is a high visibility role with a significant direct impact in the Quality Management System.
How you will make an impact as a Complaints Specialist:Assure complaint records meet QMS requirements.Perform product complaint documentation, investigation, and review of all complaint content. Responsible for reviewing Medical complaints that involve a quality related problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.Ensure that complaint documentation meets Good Documentation Practices. This requires good analytical skills, technical writing and good documentation. Maintain complaint files to meet all regulatory requirements.Identification of potentially reportable events and notification to appropriate functional groups and management.Support the site Corrective and Preventive Action program.Create and review documentation to assure it meets GMP standards and can be used for regulatory filings and/or reporting. Example: Medical Device ReportsInterface with Third Party Manufacturers, health care professionals, general public, internal customers, and regulatory agencies.Serve as a subject matter expert on complaint handling.Perform simple decontamination of returned product.Perform other related duties as assigned under management supervision.Skills needed to be successful as a Complaints Specialist:Bachelor’s degree in a STEM major with at least 1+ years work experience in a cGMP related industry or in a clinical setting is preferred. Additional experience and training considered in lieu of degree.Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.Strong written/verbal communication and organizational skills.Knowledge and application of computer systems for word processing and complaint management.Strong decision making and critical thinking skills.Motivated self-starter with a strong desire to see individual tasks through to completion, and to help in whatever manner is needed to achieve team goals.Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.Ability to learn custom software programs, multitask and carry tasks through to completion, and manage multiple sources of data to develop reports.Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
How you will make an impact as a Complaints Specialist:Assure complaint records meet QMS requirements.Perform product complaint documentation, investigation, and review of all complaint content. Responsible for reviewing Medical complaints that involve a quality related problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.Ensure that complaint documentation meets Good Documentation Practices. This requires good analytical skills, technical writing and good documentation. Maintain complaint files to meet all regulatory requirements.Identification of potentially reportable events and notification to appropriate functional groups and management.Support the site Corrective and Preventive Action program.Create and review documentation to assure it meets GMP standards and can be used for regulatory filings and/or reporting. Example: Medical Device ReportsInterface with Third Party Manufacturers, health care professionals, general public, internal customers, and regulatory agencies.Serve as a subject matter expert on complaint handling.Perform simple decontamination of returned product.Perform other related duties as assigned under management supervision.Skills needed to be successful as a Complaints Specialist:Bachelor’s degree in a STEM major with at least 1+ years work experience in a cGMP related industry or in a clinical setting is preferred. Additional experience and training considered in lieu of degree.Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.Strong written/verbal communication and organizational skills.Knowledge and application of computer systems for word processing and complaint management.Strong decision making and critical thinking skills.Motivated self-starter with a strong desire to see individual tasks through to completion, and to help in whatever manner is needed to achieve team goals.Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.Ability to learn custom software programs, multitask and carry tasks through to completion, and manage multiple sources of data to develop reports.Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is 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.
Confirm your E-mail: Send Email
All Jobs from DEKA Research & Development