Quality Engineer

Job Description

Key Responsibilities

Support the development of medical devices and/or device components of combination products by providing support on applicable design control, human factors/usability engineering, and risk management processes.

Support implementation of assurances, process controls, and Corrective Actions/Preventative Action (CAPA) systems designed to meet or exceed internal and external requirements.

Lead product risk assessment efforts, including development of quality plans for risk analysis, development of risk controls, implementation and verification of effectiveness, as well as lifecycle risk management planning.

Develop control plans, SOP's (Standard Operating Procedures), test methods, quality alerts, non-conformance trends, and monthly quality performance reports.

Represent the Quality function on product and process development project teams.

Conduct Design of Experiments (DOE) and Process Characterization for process optimization and/or improvement by conducting analyses using statistical techniques, including Gage Repeatability & Reproducibility (Gage R&R), Tolerance intervals, and Process Capability assessments.

Actively support and engage in design reviews.

Lead or support design activities including design verification, validation, specification setting and justification, test method development, usability engineering, and risk management.

Work with design engineering in the completion of product verification and validation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Performance Qualification (PPQ).

Evaluate protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.

Ensure compliance with regulatory requirements, Company policies, operating procedures, processes, and task assignments, particularly FDA 21 CFR 820, ISO 13485, and ISO 14971.