What are the responsibilities and job description for the Product Complaints Specialist position at DEKA Research & Development?
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:
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.
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.
- 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.
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.