Job Description:
A leading provider of quality and safety solutions to many of the world's top-recognized brands and companies is actively seeking a Medical Device Auditor to join our Business Assurance Team remotely. This is an excellent opportunity to grow a versatile career in Medical Device Auditing.
Our Business Assurance team goes beyond testing, inspection, and certification to examine the underlying elements that make a company and its products successful. Our assurance solutions provide confidence and peace of mind that a client's operating procedures, systems, and people are functioning correctly to provide a competitive advantage in the marketplace.
Key Responsibilities:
- Lead and participate as an assessor during all phases of a client's management system audit in accordance with the company's accredited certification program.
- Serve as the primary interface with clients before and during auditing activities.
- Train lower-graded auditors through witness audits, technical support, and education of both clients and sales force as needed.
- Conduct audits of client management systems for compliance with established standards, client and industry requirements, government regulations, and other relevant standards, specifically ISO 13485 and GMP regulatory requirements for the medical device, pharmaceutical, and cosmetic industries.
- Assist clients with questions relevant to the audit and certification process.
- Act as Lead Auditor or team member during audits.
- Coordinate audit activities with team members and liaise with clients regarding audit processes.
- Review client quality management system documentation and verify evidence of compliance and non-compliance.
- Prepare audit reports, review audit results with the assessment team, and present findings to clients and certification boards as required.
- Assist with corrective action requirements resulting from assessments and participate in audit meetings.
- Provide technical assistance and support management in continuous improvement initiatives.
Qualifications:
- Bachelor's degree in a science or technical field (e.g., biology, microbiology, chemistry, biochemistry, engineering, human physiology, medicine, pharmacy, physics) or equivalent combination of relevant education and work experience.
- Minimum of 4 years of full-time work experience in the medical device or related industry (design, development, testing, quality assurance/control).
- Minimum of 2 years in a quality management systems environment (auditing, CAPA, complaints management review).
- Completed Lead Auditor training for any standard (preferably ISO 13485 and/or relevant regulatory requirements); training provided if needed.
- Strong communication and interpersonal skills.
- Excellent organizational, analytical, and computer skills.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Effective time management skills and the ability to travel extensively (3-5 nights per week).
- Valid unrestricted driver's license and the ability to operate a motor vehicle.
Preferred Qualifications:
- Lead Auditor Training with ISO 19011 or ISO 13485 certification.
- Experience in third-party auditing and management systems.
- Knowledge of regulatory requirements for medical devices and pharmaceuticals in regions such as the EU, US, Australia, Japan, Brazil, and Canada.
- Experience implementing/auditing to ISO 13485, ISO 14971, and related standards.
- Training/experience in quality tools (e.g., Kaizen, lean manufacturing).
- Experience in a wide range of medical devices.
Physical Requirements:
- Ability to ascend/descend ladders, stairs, and ramps using feet and legs and/or hands and arms.
- Stand for sustained periods and walk to accomplish tasks.
- Communicate well through spoken word, conveying detailed, accurate information and instructions.
- Hear well, perceiving sounds with or without correction.
- Exert up to 10 pounds of force occasionally to lift, carry, push, pull, or move objects.
- Have close visual acuity to perform activities such as preparing and analyzing data, viewing a computer monitor, reading, and writing reports.
About Us:
We are a leading provider of Total Quality Assurance solutions to industries worldwide. Our network includes over 1,000 laboratories and offices in more than 100 countries. Join our global network of passionate people delivering superior customer service with a purpose of bringing quality, safety, and sustainability to life.
Diversity Statement:
We value diversity and are an Equal Employment Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics.
