Senior QMS Engineer - ISO & CAPA Leader (Medical Devices)

Actalent; Irvine (CA); On-site; USD 71,000 - 101,000; Full time

Job summary

Actalent in Irvine, CA is seeking a QMS Engineer to lead ISO quality system gap assessments and remediation for an acquired medical device company, ensuring compliance with ISO standards, FDA QSR, and MDSAP.

You will partner with Regulatory Affairs, Engineering, Operations, Supply Chain, and Quality to implement CAPA, documentation controls, and risk management, driving audits and training to maintain robust quality processes and regulatory readiness.

Qualifications

• 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.
• 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).

Responsibilities

• 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.

Skills

Quality engineering

Regulatory knowledge

CAPA processes

Root cause analysis

Documentation control

eQMS

Cross-functional leadership

Data analysis

Education

Bachelor's degree in Engineering, Quality, Biomedical Engineering, Life Sciences, or a related technical discipline

Master's degree in Engineering, Quality, Regulatory Affairs, or a related field

ASQ CQE / CQA certifications

ISO Lead Auditor certification

Tools

Microsoft Office

eQMS

Job description

Actalent in Irvine, CA is seeking a QMS Engineer to lead ISO quality system gap assessments and remediation for an acquired medical device company, ensuring compliance with ISO standards, FDA QSR, and MDSAP.

You will partner with Regulatory Affairs, Engineering, Operations, Supply Chain, and Quality to implement CAPA, documentation controls, and risk management, driving audits and training to maintain robust quality processes and regulatory readiness.