The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.
- Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
- Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
- Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
- Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
- Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
- Proficient in project management, data analysis, root cause analysis, communication, and risk determination
- Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.
- 2 years of relevant experience in a regulated industry (FDA environment preferred)
- Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard