Quality Systems Engineer

Purpose and Role

Promotes the development, implementation, and effectiveness of PFN’s Quality Management System (QMS). Supports the integration of QMS with software platforms to share and manage content, driving knowledge and metrics in a collaborative work environment.

Principal Accountabilities/Responsibilities

• Leadership of Self Improvement Planning (SIP)
• Outlines Internal Audit Plans against industry quality standards and best practices
• Creates and manages Corrective Action / Preventive Action (CAPA) Plan with metrics to monitor progress against objectives
• Performs periodic reviews of CAPAs and Internal Audits to sustain efforts
• Aids in planning and execution of External Audits and related CAPAs as needed
• Calculates, updates, and monitors quality metrics
• Works with cross-functional departments as needed to support system updates/implementations consistent with meeting quality goals
• Provides training to Team Members as required for implementing quality initiatives
• Quality Engineer Responsibility
• Acts as primary QA contact for assigned customers
• Establishes effective working relationships with assigned customers
• Investigates, determines root cause, and implements effective CAPAs for customer complaints
• Collaborates with cross-functional departments to define customer needs and meet expectations
• Receives, reviews, and initiates approval process for customer specifications
• Initiates and participates in Technical Standard Change Request (TSCR) system as needed

Education and Experience Requirements

• BS Degree in an Engineering, Technology, Mathematics, Business, or Science discipline
• 5+ years in technical role in manufacturing environment desirable
• Knowledgeable in usage and set-up of web-based applications and software packages
• Experience in Internal and External Auditing against quality standards (ISO, EDANA, and/or GMP)
• Strong written and verbal communication skills
• Demonstrated technical, business, and leadership skills
• Knowledge of quality systems (ISO, EDANA, and/or GMP)
• Skilled in statistics, problem solving, and procedure implementation
• Exceptional competence and professionalism in interactions with executive management, customers, and vendors

Physical Requirements

• Manufacturing environment
• Must comply with all safety and PPE requirements including but not limited to steel toe shoes, safety glasses and hearing protection
• Must be able to walk, talk, sit/stand, hear, reach, use computer, climb stairs, bend and twist throughout the day