Quality Engineer for NPI & High-Volume Manufacturing

Molex; Hudson (WI); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Flexible spending account

Health savings account

Life insurance

Disability insurance

Retirement plan

Paid time off

Educational assistance

Infertility assistance

Parental leave

Job summary

Molex in Hudson, WI seeks a Quality Engineer to lead product quality and validation through NPI and scale-up. You will serve as the link between customers and manufacturing, guiding process validation, controlling quality systems, and driving continuous improvements.

The role requires a bachelor's degree or 4+ years in quality/validation, with experience in manufacturing, FDA/ISO familiarity, and strong problem-solving skills.

Qualifications

• Bachelor's degree or equivalent with 4+ years in quality/validation.
• Experience in manufacturing, high volume or NPI preferred.
• Knowledge of cGMP, FDA/ISO standards are a plus.
• Strong data-driven problem solving and CAPA execution.

Responsibilities

• Lead AQP processes and define product quality criteria during NPI.
• Serve as liaison between customer and manufacturing.
• Coordinate process validation for assembly and inspection equipment.
• Create validation docs and oversee execution.
• Establish BOMs, control prints and product specs.
• Manage quality system deliverables: events, deviations, MRBs, CAPAs.
• Lead CAPA investigations with data-driven methods.
• Ensure compliance with Quality Agreements and regulatory requests.
• Develop statistical sampling and in-process control plans.

Skills

Problem solving

Communication

Quality systems

Data analysis

Education

Bachelor's degree in a related field

4+ years quality or validation experience

Tools

SAP

DOE

SPC

Job description

Molex in Hudson, WI seeks a Quality Engineer to lead product quality and validation through NPI and scale-up. You will serve as the link between customers and manufacturing, guiding process validation, controlling quality systems, and driving continuous improvements.

The role requires a bachelor's degree or 4+ years in quality/validation, with experience in manufacturing, FDA/ISO familiarity, and strong problem-solving skills.