Position Overview

We are seeking an experienced Contract Quality Auditor to support our client's quality management system through comprehensive audit activities. This role will conduct internal and supplier audits to ensure compliance with applicable regulations including FDA 21 CFR 820, ISO 13485:2016, EU MDR 2017/745, and other international regulatory requirements.

Contract Duration

6-month contract with possibility of extension based on performance and business needs

Key Responsibilities

• Plan, conduct, and lead quality system audits of internal processes and supplier facilities
• Evaluate conformance to FDA QSR, ISO 13485:2016, EU MDR, and company quality procedures
• Author detailed audit reports identifying compliance gaps and potential risks
• Verify effectiveness of corrective and preventive actions (CAPA)
• Review and assess documentation related to design controls, risk management, and product realization
• Conduct supplier qualification audits and ongoing supplier monitoring activities
• Provide recommendations for quality system improvements
• Support regulatory inspection readiness activities
• Participate in management review meetings to present audit findings and trends
• Mentor and train internal staff on audit techniques and compliance requirements

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field
• Minimum 5 years of experience conducting audits within the medical device industry
• In-depth knowledge of FDA 21 CFR 820, ISO 13485:2016, and EU MDR 2017/745
• Lead Auditor certification (ISO 13485, ISO 9001)
• Experience with risk management processes (ISO 14971)
• Strong working knowledge of design controls and product development processes
• Excellent written and verbal communication skills
• Proven ability to work independently with minimal supervision
• Ability to travel up to 40% domestically and internationally

Preferred Qualifications

• ASQ CQA (Certified Quality Auditor) or RAC (Regulatory Affairs Certification)
• Experience with MDSAP requirements
• Familiarity with IEC 60601 series standards for electrical medical devices
• Experience auditing software development processes (IEC 62304)
• Knowledge of sterilization validation requirements and processes
• Experience with combination products and/or biological materials
• Experience with EUMDR Technical Documentation assessments

Skills & Attributes

• Exceptional attention to detail and analytical skills
• Ability to communicate effectively with all levels of an organization
• Sound judgment and decision-making capabilities
• Strong project management and time management skills
• Professional demeanor and ability to handle challenging audit situations
• Ability to interpret complex regulatory requirements
• Excellent reporting and documentation skills