Overview
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.
Responsibilities
* 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.
Qualifications and Skills
* 4-year engineering degree, preferably in biomedical engineering, and 3+ years of relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis; OR a 2-year degree and 5+ years of 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).
* Experience with Salesforce.
* 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 era. 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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