Manager, Quality Engineering

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

Job summary

A leading company in medical technology is seeking a Manager of Quality Engineering to develop and manage systems ensuring regulatory compliance and risk mitigation. The role involves overseeing quality engineering functions, managing CAPA programs, and ensuring effective production monitoring. Candidates should possess a Bachelor's degree in Engineering and have significant experience in quality assurance and engineering principles.

Qualifications

• 5+ years of experience in quality assurance and quality engineering.
• Understanding of quality assurance and engineering principles.
• Knowledge of risk management throughout the product realization process.

Responsibilities

• Manage execution of Quality Engineering functions and CAPA program.
• Oversee production inspection activities and risk assessments.
• Publish monthly metrics and key process indicators.

Skills

Quality Assurance

Root Cause Analysis

Risk Management

CAPA Programs

Education

Bachelor's degree in Engineering or a related 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

1. Manage the execution of Quality Engineering functions, including oversight of the CAPA program, supplier quality program, production monitoring, and risk assessments.
2. Review and approve change requests, equipment, and tooling qualifications.
3. Oversee production inspection activities, including methods development, Prolink, and MSA studies.
4. Supervise IQC activities and calibration processes.
5. Support validation activities and respond to customer inquiries regarding complaints and quality system validation status.
6. Participate in nonconformance review with the Material Review Board.
7. Assist with external audits.
8. Publish monthly metrics and key process indicators.
9. Develop and distribute management meeting packets, including PDRs and management reviews.

Qualifications

• Bachelor's degree in Engineering or a related technical field.
• 5+ years of experience in quality assurance, quality engineering, and related tools and principles, including root cause analysis.
• Understanding of quality assurance and engineering principles.
• Knowledge of risk management and mitigation 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.