Quality Engineer

Job description

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. Equal opportunity workplace committed to diversity, inclusion, and accessibility. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Engineer based in the United States. This role offers the opportunity to serve as a key quality engineering resource within a growing medical device organization. You will support the Quality Management System across product development, manufacturing, supplier operations, and post-market activities. Working closely with Engineering, Operations, Regulatory Affairs, and external suppliers, you will investigate issues and help drive effective, compliant solutions. The position combines hands-on problem solving with continuous improvement, risk management, and quality system oversight. You will contribute to CAPA, audits, supplier quality, change management, and regulatory readiness. This is an ideal opportunity for a quality professional who enjoys cross-functional collaboration and making a measurable impact on product quality and operational effectiveness.