Lead Complaint Handling Engineer
DEKA Research & Development
DEKA R&D has an immediate opening for a Lead 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:
+ 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.
+ May lead a small team of Complaint Handling Engineers.
+ Create procedures and work instructions.
+ Increase efficiencies through process improvements.
+ Develop product training programs.
+ Generate reports to track and trend complaints across product lines.
+ Present complaint data cross-functionally.
+ Work with failure analysis team to improve 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.
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.
+ 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.
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