Junior Product Complaints Engineer

Junior Product Complaints Engineer

DEKA R&D, on behalf of Millyard Advanced Technologies is looking for a Junior Product Complaints 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.

• 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 Sales Force 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.