Medical Device Quality Engineer

About the role

The Quality Engineer II is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support for product development, manufacturing, and related systems. The role focuses on process controls, CAPA, quality systems, risk management, validation, and continuous improvement within a regulated environment.

Responsibilities

• Identify and implement effective process control systems supporting product development, qualification, and ongoing manufacturing.
• Lead implementation of process controls and CAPA systems to meet internal and external quality requirements.
• Develop and execute streamlined systems to identify, investigate, and resolve quality issues.
• Apply systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Design and conduct experiments supporting process optimization and continuous improvement.
• Prepare experiment plans, protocols, technical documentation, and reports.
• Lead process control and monitoring of Critical to Quality parameters and specifications.
• Implement product and process improvement methodologies, including Six Sigma and Lean Manufacturing.
• Lead investigations, resolution, and prevention of product and process nonconformances.
• Participate in or lead cross‑functional teams supporting quality disciplines, decisions, and practices.
• Lead completion and maintenance of risk analysis activities.
• Partner with design engineering to support product verification and validation activities.
• Work with microbiology teams to support environmental monitoring and applicable product and process requirements.
• Support Quality Management Systems and Environmental Management Systems and applicable regulatory requirements.
• Ensure compliance with Food and Drug Administration regulations, Good Manufacturing Practice requirements, company procedures, and quality processes.

Required Qualifications

• Bachelor's degree in Engineering, Technical Field, or equivalent combination of education and relevant work experience.
• Two to five years of engineering experience with demonstrated application of quality tools and methodologies.
• Detailed knowledge of Food and Drug Administration regulations, Good Manufacturing Practice, ISO 13485, and ISO 14971.
• Strong knowledge of quality engineering principles, process controls, risk management, and problem‑solving methodologies.
• Advanced computer skills, including statistical and data analysis and technical report writing.
• Strong communication, interpersonal, organizational, and follow‑up skills.
• Demonstrated project management and leadership skills with the ability to work across multiple departments.
• Ability to work independently and collaboratively in a fast‑paced, highly matrixed environment.

Preferred Qualifications

• Master's degree.
• Prior medical device industry experience.
• Experience implementing Six Sigma and Lean Manufacturing methodologies.
• American Society for Quality Certified Quality Engineer or other relevant quality certification.
• Experience working within broader enterprise or cross‑division business environments.

Schedule

• Initial training on first shift for approximately two to three months.
• After training, transition to second shift.
• Second shift hours are 3:00 PM to 11:30 PM.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long‑term disability insurance
• Short‑term disability insurance
• Paid parking/public transportation
• Paid time off
• Paid sick and safe time
• Hours of paid vacation time
• Weeks of paid parental leave
• Paid holidays annually – as applicable

Pay

$40/hr to $45/hr