Quality Engineer – MedTech Innovation & Impact

salary up to $100K

In this role, you’ll play a crucial part in maintaining product quality and regulatory compliance while working closely with cross-functional teams in engineering, manufacturing, and supplier quality. This is an opportunity to contribute to the full product lifecycle—from design and development to production and post-market quality—while growing your expertise in an industry that makes a real difference in patient outcomes.

What You'll Do:

• Ensure the integrity of the quality system by applying engineering principles to manufacturing and product development.
• Collaborate with R&D and manufacturing teams to refine designs and processes, contributing to risk analysis, verification and validation, and process improvements.
• Apply statistical methods such as Gage R&R, Cpk, ANOVA, and DOE to analyze quality trends and drive improvements.
• Use root cause analysis tools like 5-Why, FMEA, and 8D to troubleshoot and prevent quality issues.
• Conduct internal and supplier audits, support incoming inspection processes, and assess non-conformances.
• Review and approve engineering change orders, work instructions, and specifications to ensure compliance with industry standards.
• Assist in regulatory compliance, including adherence to FDA 21 CFR 820 and ISO 13485.
• Support sterilization monitoring and environmental controls.
• Lead and participate in continuous improvement initiatives to optimize quality processes.
• Some travel required for supplier support and quality audits.

What You Bring:

• Bachelor's degree in Mechanical or Biomedical Engineering (or equivalent experience).
• 3-5+ years of experience in quality or engineering for medical devices.
• Strong problem-solving skills with hands-on experience in quality tools and methodologies.
• Knowledge of regulatory standards (FDA 21 CFR 820, ISO 13485).
• Excellent attention to detail and ability to manage quality records accurately.
• Lean/Six Sigma experience is a plus.
• CQE/CQA certification or biomedical auditing experience is beneficial but not required.