Quality Management System; QMS Engineer

The Quality Management Systems (QMS) Engineer is responsible for maintaining, improving, and ensuring compliance of the Quality Management System (QMS) within a regulated medical device manufacturing environment. This role supports quality system processes including CAPA, nonconformance management, document control, internal auditing, and external regulatory and customer audits while ensuring compliance with FDA regulations, ISO 13485, and applicable customer requirements.

This QMS Engineer partners cross-functionally with Operations, Engineering, Manufacturing, Quality, Supply Chain, and Regulatory teams to drive quality system effectiveness, continuous improvement, and regulatory compliance across a medical injection molding and assembly manufacturing facility.

• Maintain and improve the site Quality Management System in accordance with:
  • FDA 21 CFR Part 820 / QMSR requirements
  • ISO 13485
  • Applicable customer and regulatory requirements
  • Internal corporate quality standards
• Support development, implementation, revision, and maintenance of quality procedures, work instructions, forms, and records.
• Ensure QMS documentation remains current, controlled, and compliant.

• Lead and coordinate Corrective and Preventive Action (CAPA) activities from initiation through effectiveness verification and closure.
• Facilitate root cause investigations using structured problem-solving methodologies such as:
  • 5 Why
  • Fishbone/Ishikawa
  • Fault Tree Analysis
  • Risk-based approaches
• Ensure timely completion of action items and maintain compliance to CAPA metrics and timelines.
• Monitor CAPA trends and identify systemic improvement opportunities.

• Manage Nonconformance Reports (NCRs) and related quality events.
• Support investigation, containment, disposition, and resolution activities for nonconforming material and product.
• Collaborate with Manufacturing Engineering, Production, and Quality teams to determine appropriate corrective actions.
• Analyze quality data and trends to drive continuous improvement initiatives.

• Administer document control processes including:
  • SOPs
  • Work instructions
  • Forms
  • Specifications
  • Validation documentation
  • Quality records
• Ensure proper revision control, approval routing, archival, and retention practices.
• Support training compliance activities associated with document revisions and implementation.

• Plan, schedule, and perform internal quality system audits.
• Participate in external audits including:
  • FDA inspections
  • ISO registrar audits
  • Customer audits
  • Supplier audits
• Support audit preparation activities and coordinate responses to audit findings.
• Track audit observations through closure and verify effectiveness of corrective actions.

• Support continuous improvement initiatives focused on quality system effectiveness and compliance.
• Assist in development and monitoring of quality metrics and KPIs.
• Participate in Management Review activities and preparation of supporting quality data.
• Promote a culture of compliance, accountability, and continuous improvement throughout the organization.

• Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline preferred.
• Minimum 3-5 years of Quality Systems experience in a regulated medical device manufacturing environment.
• Strong working knowledge of:
  • FDA 21 CFR Part 820 / QMSR
  • ISO 13485
  • Risk management principles
  • Medical device quality system requirements
• Experience with in medical injection molding, plastics manufacturing, or medical device assembly preferred.
• Hands-on experience managing:
  • CAPAs
  • NCRs
  • Internal audits
  • Document control systems
  • Regulatory and customer audits
• Experience using electronic QMS systems (eQMS) preferred.
• Strong root cause analysis and problem-solving skills.
• Excellent organizational, communication, and technical writing skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.

• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar certification preferred.
• ISO 13485 Internal Auditor or Lead Auditor certification preferred.