Quality Systems Engineer

Quality Management System Leader

Purpose of the Role The role supports the development, implementation, and effectiveness of PFN's Quality Management System (QMS). It also supports integration of the QMS with software platforms to share and manage content, enabling the capture of knowledge and quality metrics in a collaborative work environment. Where appropriate, content design drives corrective actions to deliver on quality objectives and goals.

Principal Accountabilities / Responsibilities

• QMS Continuous Improvement (SIP Leadership) Responsible for continuous improvement of PFN's QMS through 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) plans with metrics to monitor progress against objectives. Performs periodic reviews of CAPAs and Internal Audits to sustain efforts. Assists with planning and execution of External Audits and related CAPAs as needed. Calculates, updates, and monitors quality metrics. Works with cross-functional departments to support system updates and implementation consistent with meeting quality goals. Provides training to team members as required for implementing quality initiatives.
• Vision System Leadership (Reliability Troubleshooting) Serves as the Primary Vision System Leader for troubleshooting issues and providing guidance to the team responsible for system reliability. Sets up new recipes and classifiers for new products. Optimises recipes and classifiers as needed. Checks inspection systems daily. Sets up safety factors. Calibrates and validates Vision System cameras. Addresses MES issues. Coordinates with OEMs as necessary.

Education and Experience Requirements BS Degree in an Engineering, Technology, Mathematics, Business, or Science discipline. 5+ years in a technical role in a manufacturing environment is desirable. Knowledgeable in the usage and setup 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.

Work Environment Observes all safety rules and always uses proper safety equipment. 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 a computer, climb stairs, and bend and twist throughout the day.

Disclaimer The above information on this job description has been described to indicate the general nature and level of work performed by incumbents. Other duties and responsibilities not specifically described may be assigned from time to time, consistent with knowledge, skills, and abilities of the incumbent.