Quality Engineer Jobs

About The Position

Requirements

• Bachelor’s degree in Science or Engineering is required.
• Working knowledge of CDRH, CBER, and ISO regulations, including 21 CFR Part 820, ISO 13485, and ISO 14971, is required.
• Working knowledge of 21 CFR Part 11 is required.
• Must follow all applicable FDA regulations and ISO requirements.
• Understanding of statistics, SPC, and acceptance sampling is required.
• Proficient in validation methods and evaluation criteria.
• Experience with process validation, analytical method validation, cleaning validation, facility/utility qualification, and equipment qualification.
• Experience with change control processes and documentation requirements.
• Experience with electronic document management systems.
• Experience with risk analysis and PFMEA.
• Demonstrate Quality leadership in cross-functional and new product development settings.
• Work under limited supervision when leading PFMEAs, reviewing regulatory submissions, evaluating specifications, and leading department or cross-department projects.
• Support collaboration across teams during NPI and Sustaining projects.
• Communicate progress to management and escalate issues in a timely manner.
• Contribute to continuous improvement through departmental process improvement goals, improvement projects, and metrics support.
• Requires 2+ years of experience in a diagnostic, medical device, biotech, or pharmaceutical company.
• Experience should include validation activities, change control, electronic document management systems, risk analysis, and PFMEA.

Responsibilities

• Provide Quality leadership to new product development teams in validation, design transfer, risk management, and specification development.
• Author master validation plans and reports.
• Author and execute validation protocols and reports for analytical methods, equipment, facilities/utilities, raw materials, process, and cleaning.
• Review the quality, validation impact, and completeness of document change order requests and equipment or facilities change controls.
• Determine validation strategy using an acceptable risk-based approach.
• Lead cross-functional teams to write PFMEAs under limited supervision.
• Perform process risk assessments for Non-Conformance Events and planned deviations.
• Maintain validation records and support cross-functional teams during New Product Introduction and Sustaining projects.
• Review regulatory submissions and notifications under limited supervision.
• Propose improvement projects using supporting data and flowcharts.
• Assist in updating departmental procedures and controlled documents.
• Evaluate specifications for new or modified process designs under limited supervision.
• Lead department and cross-department projects, determine QE deliverables, and help create project timelines.
• Participate in process design reviews, department process improvements, and department metrics reporting.
• Assist Quality Engineering management in Material Review Board and Production Response Team meetings.
• Provide management with status updates and escalate issues in a timely manner.
• Train new employees.

Benefits

• comprehensive training when you join as well as continued development and training throughout your career
• bonus eligible