Quality Management System (QMS) Engineer

Aptyx • Olympic Woods, NC

1d • Onsite

About The Position

The Quality Management Systems (QMS) Engineer is responsible for supporting and continuously improving the Aptyx Charlotte Quality Management System (QMS) to ensure compliance with applicable regulatory requirements while fostering a culture of quality throughout the organization. This position serves as the technical subject matter expert for the site's Quality Management System and partners closely with Engineering, R&D, Operations, Manufacturing, Supply Chain, Regulatory Affairs, and Quality to drive compliance, continuous improvement, and operational excellence. Supporting the development and manufacture of innovative interventional medical devices, this role ensures that quality systems effectively support product realization from design and development through commercialization and production. The QMS Engineer leads and champions quality system initiatives including CAPA, Nonconforming Material Reports (NCRs), change management, risk management, audits, supplier quality support, management review, and regulatory compliance activities while promoting a proactive "Quality First" mindset across the organization. The ideal candidate is a collaborative leader with extensive medical device quality systems experience, exceptional analytical skills, strong regulatory knowledge, and the ability to influence cross-functional teams to continuously improve quality, compliance, and customer satisfaction.

Requirements

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Materials Science, Physics, Quality Engineering, or related technical discipline required.
• Minimum of 5 years of Quality Engineering or Quality Systems experience within the medical device industry.
• Experience supporting design and manufacturing of Class II and/or Class III medical devices preferred.
• Experience with Design Controls, Design Transfer, Risk Management, and Manufacturing Quality Systems.
• Demonstrated experience administering CAPA and Nonconformance systems.
• Internal and/or Lead Auditor experience required.
• Experience supporting FDA, ISO, customer, and MDSAP audits.
• Experience working within an R&D and manufacturing environment preferred.
• Strong knowledge of: ISO 13485, FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR), EU MDR, MDSAP, Risk Management (ISO 14971), Good Documentation Practices (GDP), CAPA methodologies, Root Cause Analysis, Statistical process analysis, Inspection and metrology techniques.
• Working knowledge of Microsoft Office Suite and electronic Quality Management Systems (eQMS).

Nice To Haves

• Experience with Minitab or equivalent statistical software preferred.
• Lean Manufacturing and Six Sigma certification preferred.

Responsibilities

• Support, maintain, and continuously improve the Aptyx Quality Management System in accordance with ISO 13485, FDA Quality System Regulations, EU MDR, MDSAP, and applicable customer requirements.
• Serve as the site's Quality Management System subject matter expert.
• Develop, revise, and maintain Quality System procedures, work instructions, forms, and supporting documentation.
• Evaluate existing quality processes and recommend improvements that increase efficiency while maintaining regulatory compliance.
• Drive a culture of continuous improvement throughout the organization.
• Champion the site's Corrective and Preventive Action (CAPA) program from initiation through effectiveness verification and closure.
• Administer the Nonconforming Material Report (NCR) process ensuring timely investigation, disposition, and resolution.
• Facilitate root cause investigations utilizing structured problem-solving methodologies.
• Monitor quality system metrics to ensure timely completion of quality system activities.
• Coordinate cross-functional teams to drive accountability for quality system deliverables.
• Monitor evolving regulatory requirements and industry standards impacting the Quality Management System.
• Assess regulatory changes and advise management regarding implementation strategies.
• Ensure ongoing compliance with: ISO 13485, FDA 21 CFR Part 820 / QMSR, EU MDR, MDSAP, Customer-specific quality requirements.
• Support customer, regulatory agency, and notified body interactions related to Quality Systems.
• Participate in risk management activities supporting product development and manufacturing.
• Review and support Design and Process FMEAs.
• Recommend improvements to risk management methodologies.
• Ensure risk management documentation complies with applicable regulatory requirements.
• Review Device History Records (DHRs), inspection documentation, validation documentation, and other quality records for completeness and compliance.
• Ensure documentation complies with Good Documentation Practices (GDP).
• Mentor and train Quality personnel on documentation review expectations.
• Support implementation of Quality System changes through effective planning, communication, training, and execution.
• Evaluate quality impact of process, equipment, documentation, and manufacturing changes.
• Ensure changes are implemented in compliance with applicable quality procedures.
• Plan, coordinate, and support internal Quality Management System audits.
• Support customer, FDA, ISO registrar, and MDSAP audits.
• Participate in supplier quality audits as required.
• Lead audit response activities including corrective action implementation and effectiveness verification.
• Analyze quality system performance metrics using statistical methods and quality tools.
• Identify trends and recommend corrective or preventive actions.
• Utilize Lean Manufacturing, Six Sigma, and continuous improvement methodologies to improve Quality System performance.
• Develop reports and dashboards supporting management decision making.
• Support sterilization validation documentation and routine sterilization activities.
• Assist in qualification and monitoring of sterilization suppliers.
• Support supplier quality activities including qualification, audits, and performance monitoring.
• Develop and deliver Quality System training programs for employees across all functional areas.
• Mentor employees on regulatory expectations and quality best practices.
• Promote organizational understanding of Quality Management System requirements.
• Support annual and periodic Management Review activities.
• Collect, analyze, and present Quality System performance metrics.
• Assist leadership in identifying opportunities for continual improvement.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level