Quality Engineer - Manufacturing Validation in Chicago
Job Description
We are seeking a hands-on Quality Engineer to support manufacturing validation and quality process development within a regulated manufacturing environment.
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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.
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Key Responsibilities
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- 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.
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Required Qualifications
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- 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.
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Qualifications
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- Experience in Product Development.
- Background supporting new product launches or early-stage manufacturing.
- Experience with manual or semi-automated assembly processes.
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Why Consider This Opportunity?
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- 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.
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