Quality Engineer II

Job Responsibilities:

• Provides Quality leadership to new product development teams in the areas of validation, design transfer, risk management and specification development.
• Author master validation plans and reports.
• Author and execute validation protocols and reports (Analytical Methods, Equipment, Facilities/Utilities, Raw Materials, Process, and Cleaning).
• Review the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities).
• Determine validation strategy based on acceptable risk-based approach.
• Lead cross-functional team to write PFMEAs under limited supervision.
• Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV).
• Assist in maintaining validation records.
• Support cross-functional teams during New Product Introduction (NPI) and Sustaining projects.
• Review regulatory submissions and/or notifications under limited supervision.
• Propose improvement projects with supporting data, flowcharts, etc.
• Assist in developing/updating departmental procedures and other controlled documents.
• Evaluate adequacy of specifications for new or modified process designs under limited supervision.
• Lead department and cross-department projects under limited supervision. Determine QE deliverables and assist in generating project timelines.
• Participate in process design reviews.
• Assist QE in Material Review Board (MRB) and Production Response Team (PRT) meetings.
• Participate in department process improvement’s goal(s).
• Assist in development, maintenance, and reporting of department metrics.
• Provides management with status updates on assigned responsibilities, goals and escalate issues in a timely fashion.

Skills:

• Proficient in validation methods and evaluation criteria.
• 2+ years of experience
• Experience with process validation, analytical method validation, cleaning validation, facility/utility and equipment qualifications.
• Experience with change control process and documentation requirements.
• Experience with electronic document management systems.
• Understanding statistics, SPC and acceptance sampling.
• Experience with risk analysis and PFMEA.
• Working knowledge of CDRH, CBER and ISO regulations (e.g., 21 CFR Part 820, ISO 13485, ISO 14971).
• Working knowledge of 21 CFR Part 11.  

Education/Experience:

• Bachelor’s degree in science or engineering