Quality Engineer

Accountabilities

• Investigate product, supplier, manufacturing, and quality system issues, supporting root cause analysis and effective resolution.
• Support CAPA activities from investigation and root cause analysis through action planning, implementation, effectiveness verification, and follow-up.
• Review design, material, supplier, process, engineering, and documentation changes and assess their potential quality and regulatory impact.
• Support risk management activities, including maintaining risk management files and evaluating changes that may affect product risk.
• Partner with Engineering, Operations, Regulatory Affairs, and suppliers to identify practical and compliant solutions to quality-related issues.
• Support supplier quality programs, including supplier issue investigations, corrective actions, change assessments, communications, and onboarding of new suppliers or contract manufacturers.
• Participate in internal audits and support external audits, regulatory inspections, and certification activities.
• Maintain and strengthen Quality Management System processes, including document control, training, quality metrics, audit readiness, and continuous improvement initiatives.
• Review quality records, change orders, engineering documentation, and other quality system records for accuracy, completeness, and compliance.
• Track quality actions and commitments to ensure they are completed, properly documented, and sustained.
• Serve as a technical quality resource to Engineering and other functional teams, providing guidance on quality system requirements, risk management, change control, investigations, and corrective actions.
• Identify opportunities to improve quality processes, operational effectiveness, and overall quality performance.

Requirements

• Bachelor’s degree in Engineering, Quality, Life Sciences, or another related technical discipline.
• 5–8 years of experience in Quality Engineering, Quality Assurance, or Quality Systems within the medical device industry.
• Working knowledge of FDA Quality System Regulation, ISO 13485, risk management principles, and medical device quality requirements.
• Demonstrated experience supporting investigations, CAPA, supplier quality activities, and change management processes.
• Experience collaborating cross-functionally with Engineering, Manufacturing, Operations, Regulatory Affairs, and suppliers.
• Strong technical problem-solving, analytical, organizational, and communication skills.
• Ability to manage multiple projects and competing priorities effectively in a fast-paced environment.
• Strong interpersonal skills and the ability to communicate quality requirements and technical issues clearly to diverse stakeholders.
• Professional proficiency in English.
• Professional proficiency with Microsoft Office applications.
• Experience working with contract manufacturers and supplier quality programs is preferred.
• Experience participating in regulatory inspections and certification audits is preferred.
• ASQ Quality Engineer certification or an equivalent quality certification is a plus.
• Experience with electronic Quality Management Systems and Product Lifecycle Management systems is preferred, with Arena experience being an advantage.

Benefits

• Base salary of $95,000–$105,000 annually.
• Comprehensive benefits package beginning on Day 1.
• Medical, dental, and vision insurance.
• Life insurance coverage.
• 401(k) plan with employer matching.
• Opportunity to contribute to quality, compliance, innovation, and continuous improvement within a medical device environment.
• Remote work arrangement.