Quality Systems Specialist (Medical Device QMS)

Job Summary

We are seeking an experienced Quality Systems Specialist with a strong background in Medical Device Quality Management Systems (QMS) to support global quality compliance initiatives. The ideal candidate will have hands-on experience with FDA 21 CFR Part 820, ISO 13485, EU MDR, ISO 14971, and quality process harmonization across cross-functional teams. Experience supporting Class II Medical Devices and Software as a Medical Device (SaMD) environments is highly preferred.

Key Responsibilities

• Support the development, implementation, and continuous improvement of the global Quality Management System (QMS).
• Ensure compliance with applicable medical device regulations, standards, corporate procedures, and quality requirements.
• Conduct gap assessments of local procedures against corporate quality requirements and regulatory standards.
• Collaborate with cross-functional teams, including Quality, Regulatory Affairs, and R&D, to harmonize and standardize quality procedures across global sites.
• Drive updates to local procedures to ensure alignment with regulatory and corporate requirements.
• Support quality system initiatives involving design controls, purchasing controls, validation activities, CAPA, and nonconformance management.
• Participate in continuous improvement initiatives using quality tools and methodologies.
• Assist with documentation, audits, and compliance activities as required.

Required Skills & Qualifications

• 5+ years of experience in Quality Systems, Quality Assurance, or Regulatory Compliance within the Medical Device industry.
• Strong knowledge of:
• • FDA 21 CFR Part 820
  • ISO 13485
  • EU MDR
  • ISO 14971
  • IEC 62304 (preferred)
• Experience developing and implementing QMS procedures, including:
• • Design Controls
  • Purchasing Controls
  • Validation
  • Nonconformance Management
  • Corrective and Preventive Actions (CAPA)
• Experience performing gap assessments and quality process harmonization.
• Proficiency with quality tools such as:
• • Root Cause Analysis
  • Six Sigma
  • FMEA
  • SPC
  • Risk Management
• Strong collaboration and communication skills with cross-functional stakeholders.
• Experience with enterprise quality systems and ERP platforms such as SAP or EtQ.
• Must be proficient in Microsoft Office Suite.

Preferred Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• Certified Quality Engineer (CQE) or equivalent certification.
• Experience supporting Software as a Medical Device (SaMD).
• Experience with Class II Medical Devices.
• Technical, engineering, or scientific background preferred.

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