Quality Engineer - Manufacturing Validation

Sterling Engineering; Chicago (IL); On-site; USD 70,000 - 110,000; Full time

Job summary

Sterling Engineering is seeking a hands-on Quality Engineer to support manufacturing validation and quality process development in a regulated environment. The role focuses on IQ/OQ/PQ validations, in-process controls, and batch release procedures to ensure readiness for production.

The ideal candidate will build validation systems from the ground up, assess risks, and collaborate with Manufacturing, Engineering, and Product Development teams to deliver reliable quality systems and improved

Qualifications

• Experience working within an ISO 13485 quality management system is required.
• Strong hands-on experience with IQ/OQ/PQ process validation.
• Experience in regulated medical device manufacturing.
• Understanding of process controls, risk assessments, and product quality.
• Ability to develop validation processes and quality systems from the ground up.
• Strong problem-solving skills and ability to work primarily onsite.

Responsibilities

• Develop and execute IQ/OQ/PQ manufacturing process validations.
• Establish in-process quality controls, inspection checkpoints, and batch release procedures.
• Assess process risks and evaluate the impact of manufacturing defects on product quality.
• Collaborate with Manufacturing, Engineering, and Product Development teams.
• Develop validation protocols, documentation, and quality procedures.
• Support manual and semi-automated manufacturing processes and new production launches.

Skills

IQ/OQ/PQ validation

Regulatory knowledge

Problem solving

Cross-functional collaboration

Tools

ISO 13485

Job description

We are seeking a hands-on Quality Engineer to support manufacturing validation and quality process development within a regulated manufacturing environment.

This role will focus on developing IQ/OQ/PQ validations, establishing in-process quality controls, and implementing batch release procedures. The ideal candidate is a resourceful problem solver who can build validation systems from the ground up and support manufacturing readiness.

Key Responsibilities

• Develop and execute IQ/OQ/PQ manufacturing process validations.
• Establish in-process quality controls, inspection checkpoints, and batch release procedures.
• Assess process risks and evaluate the impact of manufacturing defects on product quality.
• Collaborate with Manufacturing, Engineering, and Product Development teams.
• Develop validation protocols, documentation, and quality procedures.
• Support manual and semi-automated manufacturing processes and new production launches.

Required Qualifications

• Experience working within an ISO 13485 quality management system is required.
• Strong hands-on experience with IQ/OQ/PQ process validation.
• Experience in regulated medical device manufacturing.
• Understanding of process controls, risk assessments, and product quality.
• Ability to develop validation processes and quality systems from the ground up.
• Strong problem-solving skills and ability to work primarily onsite.

Preferred Qualifications

• Experience in Product Development.
• Background supporting new product launches or early-stage manufacturing.
• Experience with manual or semi-automated assembly processes.

Why Consider This Opportunity?

• Play a key role in launching a new manufacturing program.
• Build validation processes and quality controls from the ground up.
• Work closely with cross-functional engineering and manufacturing teams.
• Make a direct impact on manufacturing readiness, product quality, and process reliability.