Product Complaints Engineer - Team Lead
Company: DEKA Research & Development
Location: Manchester
Posted on: April 1, 2026
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Job Description:
DEKA R&D has an immediate opening for a Product Complaints
Engineer - Team Lead 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: Will lead a small team of Product Complaints
Engineers focused on one or more of DEKA’s innovative,
life-changing medical devices. Responsible for reviewing complaints
related to potential device-related 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. Track complaint
processes to identify areas of improvement. Author procedures and
work instructions. Establish and maintain a product training
program. Contribute independently while also collaborating with
other team members and departments. Maintain positive and
cooperative communication with co-workers, customers, contractors,
and vendors. Perform other related duties as assigned under
management supervision. Skills needed to be successful: 4-year
engineering degree, preferably in biomedical engineering, and 3
year(s) relevant experience in a cGMP environment supporting
complaint handling investigations, medical device reporting, or
product analysis; OR 2-year degree and 5 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.
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 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.
Keywords: DEKA Research & Development, Weymouth , Product Complaints Engineer - Team Lead, Science, Research & Development , Manchester, Massachusetts
