Hybrid Quality Engineer — Medical Device Validation & NPI

Energy Jobline ZR; Chicago (IL); Hybrid; USD 62,000 - 83,000; Part time

Benefits offered by this job

PTO

Paid holidays

Medical plans

Dental plan

Vision plan

401(k)

ESOP

Job summary

Energy Jobline ZR seeks a hands-on Quality Engineer to support the launch of a new medical device assembly program in Chicago, IL. This is a 1+ year hybrid contract allowing 1-2 days remote work.

You will develop IQ/OQ/PQ validations, establish in-process quality controls and batch release processes, and partner with Manufacturing, Engineering, Quality, and Product Development to build quality from the ground up.

Qualifications

• Experience validating IQ/OQ/PQ manufacturing validations.
• Experience in medical device or regulated manufacturing.
• Background in Product Development, NPI, Process Engineering, or Manufacturing Quality preferred.
• Experience with manual or semi-automated assembly processes.
• Strong understanding of process controls and product risk.

Responsibilities

• Develop and execute IQ/OQ/PQ process validations.
• Establish in-process quality controls and batch release processes.
• Support the launch of a new medical device assembly program.
• Identify quality checkpoints and controls within manual/semi-automated processes.
• Assess process risks and their impact on product quality and performance.
• Partner with Manufacturing, Engineering, Quality, and Product Development.
• Develop validation protocols, reports, and supporting documentation.
• Support troubleshooting and continuous improvement activities.

Skills

IQ/OQ/PQ validation

Manual/semi-automatic assembly

Regulated manufacturing

Process controls

Risk management

Hands-on problem solving

Cross-functional collaboration

Job description

Energy Jobline ZR seeks a hands-on Quality Engineer to support the launch of a new medical device assembly program in Chicago, IL. This is a 1+ year hybrid contract allowing 1-2 days remote work.

You will develop IQ/OQ/PQ validations, establish in-process quality controls and batch release processes, and partner with Manufacturing, Engineering, Quality, and Product Development to build quality from the ground up.