QMS Engineer

The QMS Engineer will lead and support the assessment, remediation, and integration of an acquired medical device company's Quality Management System. This role focuses on conducting comprehensive ISO quality system gap assessments, identifying compliance deficiencies, and driving corrective and preventive actions to achieve and maintain compliance with applicable regulatory and quality requirements. The QMS Engineer will collaborate closely with cross-functional teams across Regulatory Affairs, Operations, Engineering, Manufacturing, Supply Chain, and Quality to harmonize processes and strengthen the overall quality system.

• Lead and execute a comprehensive ISO quality system gap assessment of an acquired medical device company's Quality Management System.
• Review and assess quality procedures, records, processes, and documentation to determine compliance with ISO standards and applicable regulatory requirements.
• Identify quality system gaps, compliance risks, and process deficiencies, document findings, and recommend appropriate corrective and preventive actions.
• Develop and implement remediation plans to address identified gaps and achieve compliance with ISO standards, FDA Quality System Regulation (21 CFR Part 820), MDSAP, and other relevant regulations.
• Author, revise, and implement quality procedures, work instructions, forms, and quality records to ensure robust and compliant documentation.
• Lead and support Corrective and Preventive Action (CAPA) activities, including root cause investigations, corrective action planning, and effectiveness verification.
• Partner with cross-functional teams including Engineering, Operations, Manufacturing, Regulatory Affairs, Supply Chain, and Quality to implement quality system improvements and integration activities.
• Support the integration and harmonization of the acquired company's quality processes into the broader corporate quality system.
• Plan, conduct, and support internal quality audits and participate in supplier, customer, certification, and regulatory audits.
• Drive remediation activities, provide clear status updates to management, and ensure timely closure of identified quality system deficiencies.
• Facilitate risk assessments and ensure alignment with applicable risk management requirements and standards.
• Develop and deliver training on quality system requirements, revised procedures, and compliance expectations to relevant stakeholders.
• Support inspection readiness activities and contribute to responses to audit observations and regulatory findings.
• Drive continuous improvement initiatives to enhance quality system effectiveness, operational excellence, and overall compliance.

• Bachelor's degree in Engineering, Quality, Biomedical Engineering, Life Sciences, or a related technical discipline.
• Minimum of 35 years of Quality Engineering experience in the medical device industry.
• Demonstrated experience with ISO-based Quality Management Systems and medical device regulatory requirements.
• Proven experience developing and implementing quality system remediation plans and corrective actions.
• Strong knowledge of FDA Quality System Regulation (QSR) 21 CFR Part 820, CAPA processes, document control, nonconformance management, and risk management.
• Experience authoring and revising quality system procedures and controlled documents.
• Strong analytical and problem-solving skills, including root cause investigation capabilities.
• Excellent written and verbal communication skills, with the ability to clearly present complex quality and regulatory concepts.
• Ability to work independently and lead cross-functional projects in a regulated medical device environment.
• Proficiency with Microsoft Office applications and experience using electronic Quality Management Systems (eQMS).

• Experience conducting quality system audits, compliance assessments, and ISO gap analyses.
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent professional certification.
• ISO Lead Auditor certification.
• Experience supporting mergers, acquisitions, or quality system integration projects within the medical device industry.
• Experience with FDA inspections, ISO certification audits, and MDSAP audits.
• Knowledge of EU MDR requirements, ISO-based risk management standards, and design control requirements for medical devices.
• Experience working with Class II and/or Class III medical devices.
• Project management experience leading complex…