Quality Engineer – Medical Devices

We’re seeking an experienced Quality Engineer to help maintain our quality system and ensure product quality throughout the production process. You’ll use your engineering skills to support the development, design, and manufacturing of innovative medical devices.

What You’ll Do

• Support Product Development: Contribute to risk analysis, verification, and validation testing for new products.
• Use Engineering Tools: Apply statistical techniques like Gage R&R, Cpk, ANOVA, and DOE.
• Solve Problems: Use tools like cause-and-effect diagrams, FMEA, root-cause analysis, 5-Why, and 8D to address issues.
• Review and Approve: Approve engineering changes, review technical drawings, and ensure compliance with Geometric Dimensioning and Tolerancing standards.
• Maintain Records: Keep quality records accurate, thorough, and compliant.
• Conduct Audits: Perform internal and supplier audits to ensure standards are met.
• Ensure Compliance: Support incoming inspections, quality plans, work instructions, and regulatory requirements.
• Drive Improvement: Lead and participate in continual improvement projects.
• Monitor Processes: Oversee environmental and sterilization processes to maintain quality.
• Support Customer Needs: Investigate customer complaints and implement corrective actions.
• Travel: Occasionally visit suppliers as needed.

What You Bring

• A bachelor’s degree in mechanical or biomedical engineering (or equivalent experience).
• At least 5 years of engineering experience in the medical device industry (required).
• Familiarity with FDA 21 CFR 820 and ISO 13485 standards.
• Experience with aseptic production or sterilization (preferred).
• Strong written and verbal communication skills.
• Attention to detail, accuracy, and thoroughness in documentation.
• Certification as a Quality Engineer (CQE) or Quality Auditor (CQA) is a plus but not required.
• Knowledge of Lean and Six Sigma practices is helpful.