Quality Engineer

1-year W-2 contract position located onsite in Naperville, IL 60563.

About the Role

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and company systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Responsibilities

• Investigate moderately complex manufacturing product quality and compliance issues, including:
  • Investigate PRAs and complaints for manufacturing-related issues
  • Manage site NCRs, CAPAs, ECRs, and audit observations for all production processes prior to final product release based on engineering principles; analyze results
  • Provide technical support to external and internal audits
  • Make recommendations and develop reports
• Oversee product release, assess and disposition product on hold (MRB), and manage material quality control
• Review and approve equipment validations and asset management actions
• Collaborate with engineering teams to ensure successful transfers
• Develop, update, and maintain technical content of risk management files; review and revise pFMEAs in conjunction with BU PMS team where applicable for the plant site
• Develop training and documentation materials for production (e.g., work instructions) to enable seamless knowledge transfer of project and manufacturing processes
• Provide support for:
  • Process validation or support/lead TMV
  • Sustaining Quality Engineering responsibilities such as review Quality Metrics, Material Review Boards, Quality Control, etc.

Requirements

• Bachelor’s degree in engineering required
• 2–4 years of experience required

Skills

• Good documentation, communication, and interpersonal relationship skills, including negotiating and relationship management
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment
• Solid understanding and knowledge of principles, theories, and concepts relevant to engineering
• Strong problem-solving, organizational, analytical, and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to quality systems
• Strict attention to detail

Pay

$40 to $45 per hour.