What are the responsibilities and job description for the Quality Engineer, Medical Devices position at Impact Solutions Inc?
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.
Salary : $85,000 - $100,000
