Job Description

The Quality Assurance Auditor is responsible for planning, conducting, documenting, and reporting internal quality system audits to ensure compliance with applicable regulatory requirements, international standards, and company procedures. This role supports the effectiveness of the Quality Management System (QMS) through independent assessments, and participation in customer audits, certification audits, and regulatory inspections. The Quality Assurance Auditor partners with cross-functional teams to identify compliance risks, verify corrective actions, and promote continuous improvement across the organization.

Duties & Responsibilities:

• Plan, conduct, and document QMS internal audits in accordance with established audit schedules and company procedures.

• Evaluate compliance with applicable regulations, standards, and quality system requirements, including ISO 13485, 21 CFR Part 820, EU MDR 2017/745 and other relevant global regulatory requirements.

• Evaluate the effectiveness of quality system processes and ensure they are adequately documented, implemented, and maintained.

• Develop audit plans and agendas, and communicate audit objectives, scope, and schedules to relevant stakeholders in advance.

• Prepare comprehensive audit reports, communicate audit findings, and facilitate the timely execution of corrective and preventive actions (CAPAs).

• Verify implementation and effectiveness of corrective actions resulting from internal, customer, and third-party audit findings.

• Support customer audits, certification audits, and regulatory inspections by coordinating audit activities and providing required documentation.

• Maintain audit records and documentation in accordance with company procedures and regulatory requirements.

• Collaborate with Quality, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, and other functional groups to address compliance issues and improve processes.

• Monitor changes to applicable regulatory and quality system requirements and support implementation efforts to ensure ongoing compliance.

• Contribute to quality metrics reporting, management reviews, risk-based decision-making, and continuous improvement initiatives.

• Perform additional duties and responsibilities as assigned.

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• ISO 13485 Lead Auditor certification..

• Minimum of five (5) years of experience conducting internal audits within the medical device or pharmaceutical industry.

• Strong knowledge of quality management systems and auditing principles, including Medical Device Single Audit Program (MDSAP) audit approach.

• Thorough understanding of ISO 13485, 21 CFR Part 820, EU MDR 2017/745 and other applicable global standards and regulations.

• Working knowledge of CAPA, risk management, and quality system improvement methodologies.

• Strong analytical, critical thinking, organizational, and problem-solving skills.

• Demonstrated ability to manage multiple priorities, meet deadlines, and work independently with minimal supervision.

• Excellent written and verbal communication skills.

• Proficiency in Microsoft Office applications and electronic quality management systems.

• Ability to effectively communicate audit findings and recommendations to various levels of the organization.

Preferred Qualifications:

• Experience supporting customer audits, certification audits, and regulatory inspections.

• Working knowledge of ERP systems and electronic document management systems.

Education:

Bachelor's degree in Engineering, Life Sciences, Quality Assurance, Manufacturing, or a related discipline.

Language requirements

• Ability to read, write, and communicate effectively in English.

• Ability to interpret technical documents, schematics, and written instructions.

• Ability to clearly document technical findings and communicate with cross-functional team members.

Physical requirements/Work Environment

This position primarily works in an office environment and requires frequent sitting, standing, and walking. Daily use of a computer and other digital devices is required. This role may require standing for extended periods when facilitating meetings or walking through facilities.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Masimo is proud to be an EEOE/, M/F/D/V, and we are committed to Diversity at the corporate level.