Quality Systems Lead — Plant-Wide Manufacturing Excellence

Actalent; Fort Wayne (IN); On-site; USD 40,000 - 46,000; Full time

Job summary

Actalent in Fort Wayne, IN is seeking a Quality Engineer to serve as the primary quality representative for a new U.S. manufacturing facility.

You will develop and implement plant-wide quality standards, drive root cause analysis, corrective actions, and establish metrics and documentation to support continuous improvement across production and engineering teams. You will lead customer-focused quality activities, perform audits, support PFMEA, PPAP, and ensure alignment with ISO 9001/IATF9001

Qualifications

• Bachelor's degree in an engineering field.
• 13 years of experience in manufacturing quality engineering.
• Familiar with ISO 9001 and/or IATF standards.
• Experience with RCA, PFMEA, SPC, MSA, and audits.
• Knowledge of AS9100, quality data interpretation, and cross-functional communication.
• Ability to work independently and in teams.

Responsibilities

• Lead plant-wide quality standards, procedures, and systems.
• Act as main liaison for customer quality concerns and resolution.
• Drive root cause analysis and corrective actions for issues.
• Establish and report key quality metrics and documentation.
• Develop and maintain control plans, inspection procedures, and SOPs.
• Collaborate with production/engineering to improve quality and process capability.
• Support PFMEA, process flow diagrams, control plans, and new process development.
• Conduct quality system audits and ensure compliance.
• Manage calibration, gauge control, and MSA activities.
• Coordinate with suppliers and global quality teams on standards.
• Utilize SPC and data-driven methods for process monitoring.
• Prepare PPAP documentation as needed.

Skills

Quality engineering

Root cause analysis

SPC/MSA

Cross-functional teamwork

Customer communication

Data interpretation

Education

Bachelor's degree in Engineering

Tools

Minitab

GD&T

PFMEA

Excel

MSA

SPC

PPAP documentation

Job description

Actalent in Fort Wayne, IN is seeking a Quality Engineer to serve as the primary quality representative for a new U.S. manufacturing facility.

You will develop and implement plant-wide quality standards, drive root cause analysis, corrective actions, and establish metrics and documentation to support continuous improvement across production and engineering teams. You will lead customer-focused quality activities, perform audits, support PFMEA, PPAP, and ensure alignment with ISO 9001/IATF9001