Quality Assurance Engineer
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 customer communication regarding complaints and regulatory compliance request
- 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 via Minitab, Infinity QS or other methods
- 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.