Quality Engineer III

About the Role

An established manufacturer in the regulated healthcare industry is seeking a Quality Engineer III to support product development, manufacturing, and quality system activities. This position partners closely with engineering, operations, and customers to ensure products and processes meet quality, regulatory, and customer requirements.

Responsibilities

• Lead quality activities for new product and process development projects.
• Support validation, process characterization, statistical analysis, and inspection planning.
• Investigate nonconformances, perform root cause analysis, and implement corrective actions.
• Analyze product and process performance using statistical tools and quality metrics.
• Support customer complaints, audits, and continuous improvement initiatives.
• Collaborate cross-functionally to maintain compliance with quality system requirements.
• Provide technical guidance and mentorship to team members.

Qualifications

• Bachelor's degree in Engineering or related technical field preferred.
• 5+ years of quality engineering experience in a regulated manufacturing environment.
• Experience with process validation, root cause analysis, SPC, DOE, CAPA, and quality systems.
• Knowledge of ISO 13485, ISO 9001, or similar quality standards preferred.
• Proficiency with statistical analysis tools and ERP/MRP systems.
• Strong problem-solving, communication, and project management skills.
• ASQ CQE certification and medical device experience are a plus.

Pay

Competitive salary: $100,000 - $117,000

Benefits

• Bonus opportunity
• Comprehensive health benefits
• 401(k) with company match
• Paid time off
• Professional development and tuition assistance