Quality Engineer

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. This role may also include working with the New Product Introduction (NPI) team to integrate new products developed by R&D into the manufacturing environment.

Job Duties:

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.

Minimum Requirements:

Bachelor's degree in Engineering

Preferred Requirements:

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