Quality Engineer 2

The position is responsible for validation activities covering analytical methods, cleaning, production processes, equipment qualification, facilities/utilities qualification, and raw materials qualification. The role also includes generating and maintaining process FMEA, performing risk assessments for process-related non-conformances and planned deviations, supporting regulatory submissions, writing master validation plans, protocols, and reports, supporting equipment and facilities change controls, and performing validation impact assessments for change orders 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.

Knowledge

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.

Behavior

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.

Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training