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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.

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