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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.

Essential Duties & Responsibilities

Quality Management System Leadership

• 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.

CAPA, NCR & Quality Systems Management

• 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.

Compliance & Regulatory Support

• 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.

Risk Management

• 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.

Documentation & Record Review

• 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.

Change Management

• 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.

Audits

• 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.

Data Analysis & Continuous Improvement

• 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.

Sterilization & Supplier Quality Support

• 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.

Training & Mentorship

• 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.

Management Review

• Support annual and periodic Management Review activities.
• Collect, analyze, and present Quality System performance metrics.
• Assist leadership in identifying opportunities for continual improvement.

Qualifications

Education

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Materials Science, Physics, Quality Engineering, or related technical discipline required.

Experience

• 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.

Technical Knowledge

• 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
• Experience with Minitab or equivalent statistical software preferred.
• Lean Manufacturing and Six Sigma certification preferred.
• Working knowledge of Microsoft Office Suite and electronic Quality Management Systems (eQMS).

Core Competencies

Commitment to Quality

Maintains the highest standards of quality, compliance, and patient safety while ensuring processes consistently meet regulatory and customer expectations.

Continuous Improvement

Drives process optimization through data analysis, structured problem solving, and implementation of sustainable improvements.

Collaboration

Builds strong cross-functional relationships and works effectively with Engineering, Operations, R&D, Manufacturing, Regulatory Affairs, and customers to achieve organizational objectives.

Accountability

Takes ownership of quality system performance, follows through on commitments, and delivers timely, compliant results.

Communication

Communicates technical information clearly and effectively while influencing stakeholders at all organizational levels.

Leadership & Influence

Serves as a trusted technical advisor who promotes a proactive quality culture and positively influences decision-making across the organization.

Analytical Thinking

Applies sound engineering principles and critical thinking to solve complex quality and compliance challenges.

Customer Focus

Understands internal and external customer requirements and works proactively to ensure quality systems support exceptional customer satisfaction.

Physical Requirements

• Ability to work in office, laboratory, manufacturing, and ISO Class 7/8 cleanroom environments.
• Ability to stand, walk, bend, and occasionally lift up to 25 pounds.
• Ability to wear required cleanroom garments and personal protective equipment.
• Ability to use computers and standard office equipment for extended periods.
• Ability to visually inspect documentation and manufactured components.

Travel

• Approximately 5% travel, including supplier audits, customer visits, and occasional training or business meetings.

Acknowledgement

I have received a copy of this job description, have read and understood it, and will complete all assigned duties and responsibilities. I recognize that the company reserves the right to modify this job description and that I will be informed of any and all modifications prior to their effective date.

Employee Signature

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