Complaint Handling Engineer

• 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.