Product Complaints Engineer - Team Lead

Product Complaints Engineer - Team Lead

DEKA R&D, on behalf of Millyard Advanced Technologies, is looking for a Product Complaints Engineer - Team Lead to work in a dynamic Medical Device 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.