Quality Management System; QMS Engineer

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.

• 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.

• 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…