Sr. Quality Engineer

Position Summary

We are seeking a Senior Quality Engineer to support quality initiatives across product development, manufacturing, and post-market activities for a growing medical device organization. This individual will partner with cross-functional teams to ensure products consistently meet quality, regulatory, and customer requirements while driving continuous improvement efforts throughout the product lifecycle.

Key Responsibilities

• Provide quality engineering support for new and existing medical device products.
• Lead investigations related to product quality issues, nonconformances, and customer complaints.
• Support and drive Corrective and Preventive Action (CAPA) activities, including root cause analysis and effectiveness verification.
• Collaborate with Manufacturing, Supplier Quality, Regulatory Affairs, and R&D teams to resolve quality issues and implement sustainable solutions.
• Participate in risk management activities, including risk assessments and FMEA updates.
• Support design changes, process improvements, and product transfers through established quality system processes.
• Review and approve quality documentation, protocols, reports, and engineering changes.
• Analyze quality metrics and trends to identify opportunities for continuous improvement.
• Assist with internal and external audits, inspections, and regulatory compliance activities.
• Provide quality oversight for products that may include medical devices, combination device technologies, and associated manufacturing processes.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• Several years of quality engineering experience within the medical device, life sciences, or regulated manufacturing industry.
• Working knowledge of quality systems, risk management, and problem-solving methodologies.
• Experience supporting cross-functional projects and driving quality improvements.
• Familiarity with FDA regulations, ISO standards, and industry best practices.
• Strong analytical, communication, and organizational skills.

Preferred Qualifications

• Experience supporting product development, manufacturing, or sustaining engineering activities.
• Knowledge of validation, verification, and statistical analysis methodologies.
• Experience participating in audits and regulatory inspections.
• Certification in Quality Engineering or related discipline is a plus.

What You'll Bring

• A proactive and collaborative approach to problem solving.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong technical judgment and attention to detail.
• Commitment to product quality, patient safety, and continuous improvement.