Quality Engineer

Crown Point, IN

Full Time

Mid Level

Point Medical
Location: Crown Point, IN
Job Type: Hybrid
Local candidates only need apply, must be within reasonable commuting distance as on-site work is required.
Relocation Assistance and Sponsorship are NOT offered for this position.

We’re Hiring: Quality Engineer (Medical Device Manufacturing)

Join our team as a Quality Engineer and help ensure the safety, reliability, and compliance of life‑changing medical devices. In this fast‑paced manufacturing environment, you’ll drive continuous improvement, support validations, lead CAPA investigations, and help maintain a world‑class quality system aligned with FDA 21 CFR 820 and ISO 13485.

What You’ll Do:

Support and maintain compliant quality systems
Lead CAPA and root cause investigations
Support IQ/OQ/PQ validations and internal/external audits
Develop inspection methods and program vision systems (Keyence, Starrett, ROI)
Analyze quality data and support continuous improvement initiatives
Contribute to risk management, supplier quality, and documentation (DHR/DMR/DHF)

What We’re Looking For:

Experience in medical device or regulated manufacturing
Knowledge of FDA 820, ISO 13485, ISO 14971
Skills in statistical tools (Minitab/JMP); Six Sigma or ASQ certifications a plus
Strong technical writing and ability to manage multiple priorities

If you’re a proactive problem-solver with a passion for quality and compliance, we’d love to talk!
Apply today and help shape the future of safe, innovative medical devices.

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VISION & MISSION STATEMENT

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Quality Engineer

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