Quality Engineer

Job Overview

Seeking an experienced Quality Engineer to lead quality enhancement and project management efforts in a manufacturing setting. This role involves managing multiple cross-departmental projects from conception to production, ensuring products meet regulatory standards, quality benchmarks, and delivery timelines.

Key Responsibilities

• Oversee quality engineering projects with comprehensive control over scope, schedule, budget, and risk factors.
• Guide collaborative teams that include Engineering, Manufacturing, Quality Assurance, Supply Chain, and Suppliers.
• Support stages including New Product Introduction, process transitions, launch activities, and readiness for manufacturing.
• Plan and carry out validation procedures such as IQ/OQ/PQ, along with APQP, PPAP, FMEA, control plans, and process qualifications.
• Perform in-depth root cause evaluations employing 8D, Fishbone diagrams, and 5 Whys techniques to solve quality problems and implement corrective actions.
• Implement continuous improvement leveraging Lean principles, Six Sigma methodologies, and statistical tools.
• Manage Engineering Change Orders and maintain robust change control and documentation.
• Coordinate supplier quality audits, inspections, and oversee corrective measures as needed.
• Monitor key performance indicators and deliver concise status updates and presentations to leadership teams.
• Maintain compliance with industry regulations such as ISO 9001, ISO 13485, AS9100, IATF 16949, and FDA/cGMP as relevant.

Required Qualifications and Skills

• Proficiency in project management tools including MS Project, Smartsheet, and Primavera.
• Deep knowledge of quality engineering practices in manufacturing environments.
• Experience with CAPA processes, NCR documentation, and root cause analysis (8D, 5 Whys).
• Competence in APQP, PPAP, DFMEA/PFMEA, and development of control plans.
• Expertise in IQ/OQ/PQ validation and verification procedures.
• Strong background in Lean Manufacturing techniques and Six Sigma practices.
• Applied skills in GD&T, Statistical Process Control, and statistical software such as Minitab.
• Experience managing supplier quality, conducting audits, and overseeing corrective actions.
• Effective cross-functional leadership and superior communication abilities.

Industries Served

• Medical Devices
• Automotive
• Aerospace
• Industrial Manufacturing
• Pharmaceutical Manufacturing
• Consumer Products