Senior Quality Engineer

Job Description

Job Description

Description : Position Summary

The Senior Quality Engineer develops, implements, and improves commercial product quality requirements, and is committed to improving the quality of patient care and improving the effectiveness of the quality management system. As a senior level and hands-on resource , this position leverages medical device quality, supplier and manufacturing experience to lead sustaining risk management activities, support root cause analysis, and provide technical support for process verification and validation activities.

Job Duties / Responsibilities

• Develops, maintains and evaluates risk management file including supporting FMEAs
• Develops and maintains the master validation plan in support of sustaining processes and equipment. Writes test method validation, equipment qualification and process validation protocols / reports.
• Collaborate with cross-functional team (including Supply Chain, Manufacturing, Suppliers, Regulatory, etc.) to communicate, understand and solve quality problems.
• Evaluate product quality risks and acceptability of nonconforming materials
• Provides investigative support for product quality issues.
• Utilize root cause analysis techniques to identify potential solutions to address those root causes within the corrective and preventive action system.
• Develop new processes which support speed, cost reductions and quality improvements.
• Drive continuous improvements through observation, measurement and root cause analysis.
• Perform statistical analysis in support of root cause analysis, process control, and verification and validation activities.
• Support the selection, qualification, and certification of responsible suppliers to provide materials that meet specifications for production requirements.
• Maintain supplier relationships that encourage technical input and contributions, as requested, concerning new products, processes, ideas, and improvements. Initiate actions required to maintain excellent supplier performance.
• Embodies the Company’s purpose and shared values, building a positive and productive team culture.
• Comply with Company policies and procedures.
• Authorized to access employee and / or patient PHI and ePHI only as needed for job-related functions.
• Other duties as assigned.

Requirements : Qualifications

Physical Demands / Working Conditions