How you will make an impact:
- Responsible for reviewing complaints related to potential medical device issues.
- 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.
- 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.
- Work with the forensic investigation team to align product investigations related to complaints.
- Generate reports to identify areas of process improvement.
- Develop product training aids.
- 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 biomedical engineering degree; OR 2-year biomedical engineering degree and 2+ year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis.
- Experience in complaint handling or quality engineering preferred (school projects and internships considered)
- 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.
- 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 Millyard Advanced Technologies:
https://millyardadvanced.com/
Located in the heart of the Regen Valley in Manchester, NH, our company aims to positively influence the healthcare landscape.
- Contract Designer: DEKA Research & Development
- Contract Manufacturer: Merrimack Manufacturing
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.
Skills Required
- Bachelor's degree (4-year) in Biomedical Engineering OR Associate degree (2-year) in Biomedical Engineering plus 2+ years relevant experience in a cGMP environment supporting complaint handling or product analysis
- Experience in complaint handling or quality engineering (school projects and internships considered)
- Knowledge of FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 820, 211)
- Experience with Salesforce
- Familiarity with cGMP and Good Documentation Practices
- Proficient computer skills and good problem-solving ability
- Exceptional time management and ability to prioritize multiple projects
- Solid written and verbal communication, organizational skills, attention to detail, and technical writing ability
- Ability to work independently and on cross-functional teams in a fast-paced environment
What We Do
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester. DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, designers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality. DEKA is filled with people who are driven to be among the best and brightest in their field of work. It’s a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.
