What are the responsibilities and job description for the Complaint Handling Engineer position at DEKA Research & Development?
DEKA R&D has an immediate opening for a Complaint Handling Engineer to work in a dynamic Medical Device Research and Development environment. The position reports to the Product Complaints Manager. This is a high visibility role with a significant direct impact in the Quality Management System.
How you will make an impact:
How you will make an impact:
- Responsible for reviewing complaints that involve a potential quality problem with a medical device.
- Perform product complaint evaluations with minimal direction, utilizing experience and product knowledge.
- 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.
- Identify and make sound decisions regarding medical device reporting to regulatory agencies.
- Edit procedures and work instructions.
- Develop product training aids.
- Generate reports to track and trend complaints across product lines.
- Work with failure analysis team to inform product investigations related to complaints.
- Interface with Third Party Manufacturers, health care professionals, internal customers, and regulatory agencies.
- Participate in audits and CAPA investigations as they relate to complaint handling.
- Contribute independently while also collaborating with other team members and departments needing product complaint information.
- Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors.
- Serve as a subject matter expert on complaint handling.
- Perform other related duties as assigned under management supervision.
- 4-year engineering degree, preferably in biomedical engineering; OR 2-year degree and 2 year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis.
- Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
- Experience with SalesForce is preferred.
- 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.
- Excellent time management skills with the ability to prioritize multiple projects and ensure compliance with regulations and standard operating procedures.
- Ability to work well independently and on cross-functional teams in a fast-paced, changing environment.
- Motivated self-starter with a strong desire to see individual tasks through to completion, and to help as needed to achieve team goals.
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.
