Quality Systems Engineer

• Support the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, IEC 62304, EU MDR, ISO 14971, and corporate quality procedures.
• Perform gap assessments of local procedures against corporate standards and regulatory requirements.
• Collaborate with cross-functional teams to update and standardize quality procedures, tools, and best practices.
• Support QMS elements including Design Controls, Purchasing Controls, Validation, Non-Conformance Management, CAPA, and Change Control.
• Drive continuous improvement initiatives to strengthen quality systems and regulatory compliance.
• Partner with Regulatory Affairs, R&D, and Quality teams to ensure alignment with quality objectives.

Do you have a valid Certified Quality Engineer certification?, Do you have experience in Six Sigma methodology implementation?, * 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
• Experience developing and implementing Quality Management System (QMS) procedures.
• Hands-on experience with CAPA, Design Controls, Purchasing Controls, Validation, and Non-Conformance Management.
• Familiarity with quality tools and methodologies including Root Cause Analysis, Risk Management, FMEA, SPC, and Six Sigma.
• Experience collaborating with cross-functional teams including Quality, Regulatory Affairs, and R&D.
• Proficiency with Microsoft Office Suite., * Previous experience in the Medical Device industry is required.
• Experience with Software as a Medical Device (SaMD) and/or Class II Medical Devices is preferred.
• Experience with enterprise quality systems such as SAP or EtQ.
• Bachelor’s degree in Engineering, Science, or a related technical discipline preferred.
• CQE or equivalent quality certification is a plus., * Quality Management System (QMS)
• FDA 21 CFR Part 820
• ISO 13485
• IEC 62304
• EU MDR
• ISO 14971
• CAPA
• Design Controls
• Validation
• Risk Management
• FMEA
• Root Cause Analysis
• Medical Device Compliance
• SAP / EtQ
• Cross-Functional Collaboration

If you have strong experience supporting Quality Systems in a regulated medical device environment and are passionate about driving compliance and continuous improvement, we’d love to hear from you.

$50 - $52 an hour - Contract