Product Complaints Engineer
On-siteManchester, New Hampshire, United States
Job Summary
Review medical device complaints and perform independent evaluations with minimal direction, ensuring documentation adheres to Good Documentation Practices, QMS requirements, and FDA regulations. Identify reportability for regulatory agency submissions, interface with third-party manufacturers and healthcare professionals, and participate in audits and CAPA investigations. Collaborate with the forensic investigation team to align product investigations, generate process improvement reports, and develop training aids. Serve as a subject matter expert while maintaining positive communication with internal and external stakeholders. Manage a high-volume workload independently, driving records to closure within established timelines.
Required Qualifications
- 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
- 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
- Ability to thrive in a fast-paced, changing environment while maintaining compliance with regulations, procedures, and quality system requirements
- 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
Desired Qualifications
- Experience with ISO 13485
- 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
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.