Product Complaints Engineer

About the role

DEKA R&D, on behalf of Millyard Advanced Technologies, is seeking a Product Complaints Engineer to join their dynamic Medical Device Research and Development team. The position reports to the Product Complaints Manager and plays a crucial role in the Quality Management System.

Responsibilities

• Review complaints related to potential medical device issues
• Perform product complaint evaluations with minimal direction, utilizing experience and product knowledge
• Ensure 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

Requirements

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline required
• Minimum of 3-5 years of experience in a regulated medical device, pharmaceutical, or life sciences environment, with direct responsibility for complaint investigations, product quality investigations, product analysis, and complaint closure activities
• Demonstrated experience conducting complaint investigations, determining root cause, documenting investigation results, and independently driving records to closure in compliance with established timelines
• Working knowledge of FDA Quality System Regulations, Medical Device Reporting requirements, and applicable standards, including 21 CFR Parts 803 and 820; experience with ISO 13485 is preferred
• Experience evaluating product complaints for reportability and supporting regulatory submissions is preferred
• Experience using electronic quality management systems (eQMS), complaint handling systems, and platforms such as Salesforce is preferred
• Strong technical troubleshooting, analytical, and problem-solving skills with the ability to assess complex product performance issues and identify potential failure modes
• Exceptional time management skills with the ability to manage a high-volume complaint workload while meeting regulatory and internal closure targets
• Excellent technical writing skills with demonstrated ability to prepare clear, concise, and compliant investigation reports
• Strong written and verbal communication skills with the ability to effectively interact with Quality, Regulatory, Engineering, Manufacturing, Clinical, and Customer Support teams
• Highly organized, detail-oriented, and self-motivated with the ability to work independently and make sound decisions based on available evidence
• Ability to thrive in a fast-paced, changing environment while maintaining compliance with regulations, procedures, and quality system requirements

Qualifications

• Must be able to pass a background check
• Must be legally authorized to work in the United States without need for employer sponsorship, now or in the future

Skills

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline
• Minimum of 3-5 years of experience in a regulated medical device, pharmaceutical, or life sciences environment
• Working knowledge of FDA Quality System Regulations, Medical Device Reporting requirements, and applicable standards
• Experience evaluating product complaints for reportability and supporting regulatory submissions
• Experience using electronic quality management systems (eQMS), complaint handling systems, and platforms such as Salesforce
• Strong technical troubleshooting, analytical, and problem-solving skills
• Exceptional time management skills
• Excellent technical writing skills
• Strong written and verbal communication skills
• Highly organized, detail-oriented, and self-motivated
• Ability to thrive in a fast-paced, changing environment

Benefits

• Competitive salary
• Health insurance
• Retirement plan
• Flexible work schedule
• Professional development opportunities

Pay

• $75,000 - $90,000 annually

Schedule

• Full-time