Quality Engineer

Ledgent Technology; Naperville (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

Ledgent Technology in Naperville, IL, seeks a quality engineer to apply quality principles across product development and manufacturing. You will support compliance, investigations, and continuous improvement within regulated environments.

You will collaborate with engineering and operations, review NCRs and CAPAs, assist audits, and help transfer processes while developing documentation and training materials for production teams.

Qualifications

• 2-4 years of experience in quality engineering.
• Good documentation, communication and interpersonal skills.
• Basic understanding of statistical techniques.
• Experience working with lab/industrial equipment.
• Solid understanding of engineering principles.
• Strong problem-solving and analytical thinking.
• Attention to detail and adherence to quality systems.

Responsibilities

• Investigate moderately complex manufacturing quality and compliance issues.
• Review NCRs, CAPAs, ECRs and audit observations prior to release.
• Provide technical support for internal and external audits.
• Develop reports and recommendations.
• Oversee product release and disposition, MRB handling.
• Review equipment validations and asset management actions.
• Collaborate with engineering for transfers.
• Develop training materials for production and knowledge transfer.

Skills

Documentation

Communication

Interpersonal skills

Statistical techniques

Lab/Industrial equipment experience

Engineering principles

Problem solving

Attention to detail

Tools

Lab equipment

Job description

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.

Key Responsibilities:

• Investigate moderately complex manufacturing product quality and compliance issues which may include:
  • 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
• May 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 the seamless knowledge transfer of project and manufacturing processes
• Provides support to the following:
  • Process validation or support/lead TMV
  • Sustaining Quality Engineering responsibilities such as review Quality Metrics, Material Review Boards, Quality Control etc.

Education/Experience:

• 2-4 years experience required.

Additional Skills:

• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid 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

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.