Manager, Quality Engineering

Cook Group; Bloomington (IN); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in polymer technology is seeking a Manager, Quality Engineering to ensure regulatory compliance and manage quality systems. The role involves overseeing quality functions, managing CAPA programs, and supporting validation activities. Ideal candidates will have a Bachelor's degree in Engineering and extensive experience in quality assurance.

Qualifications

• 5+ years of experience in quality assurance and engineering.
• Understanding of quality assurance principles.
• Proficiency in leading CAPA programs.

Responsibilities

• Manage Quality Engineering functions including CAPA and supplier quality.
• Oversee production inspection activities and risk assessments.
• Publish monthly metrics and support validation activities.

Skills

Quality assurance

Quality engineering

Root cause analysis

Risk management

CAPA programs

Education

Bachelor's degree in Engineering or a technical field

Job description

Overview

The Manager, Quality Engineering at Cook Polymer Technology is responsible for developing and managing systems that ensure regulatory compliance and mitigate potential risks related to quality issues.

Responsibilities

• Manage the execution of Quality Engineering functions, including oversight of the CAPA program, supplier quality program, production monitoring, and risk assessments.
• Review and approve change requests, equipment, and tooling qualifications.
• Oversee production inspection activities, including methods development, Prolink, and MSA studies.
• Supervise IQC activities.
• Oversee calibration activities.
• Support validation-related activities.
• Assist with customer inquiries regarding complaints and quality system validation status.
• Support the Material Review Board for nonconformance reviews.
• Assist with external audits.
• Publish monthly metrics and key process indicators.
• Develop and distribute management meeting packets, including PDR and management review.

Qualifications

• Bachelor's degree in Engineering or a technical field.
• 5+ years of experience related to quality assurance, quality engineering, and quality tools and principles, including root cause analysis.
• Understanding of quality assurance and quality engineering principles.
• Knowledge of risk management and mitigation activities throughout the product realization process.
• Proficiency in leading effective CAPA programs.

Physical Requirements:

• General office environment.
• Sedentary work, exerting up to 10 pounds of force occasionally. Involves long periods of sitting.
• Requires close visual acuity for working with computers and equipment.
This job description reflects management's assignment of essential functions; it does not restrict management's right to assign or reassign duties and responsibilities at any time.