- Perform 3rd party onsite/remote audits for ISO 13485 Management systems for North American Customers.
- Provide 3rd party audits and associated services to customers regarding assigned standards and applicable registration program requirements.
- Plan and conduct all assessment activities, including documentation reviews (desk audits) preliminary assessments (baseline audits), On-site Readiness Reviews, registration, reassessment, and surveillance audits.
- Lead audit team and be responsible for successful accomplishment of assigned projects.
- Build professional relationships with NSF clients.
- Review and forward audit reports, client responses to audit nonconformities, and other necessary technical documentation.
- Maintain Schedule of audit activities
- Uphold appropriate auditor credentials and other related credentials as needed.
- Attend any additional training needed related to business needs.
- Perform other duties as requested by Audit Management team.
- Communicates effectively with clients, and account managers.
- Contribute to the growth and development of a world-class, industry leading auditing team.
- Completion of accredited 13485 Lead Auditor class
- Medical Industry Experience
- Bachelor's degree in a related field (i.e., Engineering, Bioscience, Biomedical, Science, etc.)
- Minimum of 4 years of experience auditing for ISO 13485 standard.
- For 13485, this is clarified to mean appropriate knowledge and skills of "medical devices and applicable legal requirements".
- Completed training on medical device risk management (e.g. ISO
- Previous rd party auditing experience.
- Completed ISO 9001:2015 certification or willing to obtain.
- Will pursue advancement of those credentials and other related credentials as needed
- Ability to show an audit log.
- Willingness and ability to work independently.
- Ability to travel extensively throughout North America
- Position based from your home location, relocation not required
- Must be authorized to work in the United States on an unlimited basis without sponsorship.
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Senior Auditor ISR - Ann Arbor, United States - NSF
Description
Job DescriptionThe Independent Contract Auditor will be responsible for communicating effectively with external clients and internal Account Managers.
Responsibilities
Principal Accountabilities include, but are not limited to:
About Us
NSF is a growing global public health and safety organization. Our mission is to protect and improve human and planet health by enabling safe food, clean water and life-enhancing health technologies and products for millions of people around the world. We do so by developing standards, testing, auditing, certifying, and providing advisory services to clients in the food, water, health sciences and consumer industries.
Our nearly 3,000 employees provide services in over 180 countries through many of our global offices, at our 35,000 client sites, from home offices and in state-of-the-art laboratories. We're growing fast and expanding into new areas such as sustainability and digital. And that's where you come in. Come join a team that makes a difference in the world.
More information about NSF can be found at
One of our core values is We Are One NSF. This means that while we're one team, we embrace the cultural, ethnic, language and demographic diversity that reflects the societies in which we live and work. NSF is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.
About the Team
NSF International Strategic Registrations (NSF-ISR) offers comprehensive management systems certification to internationally accepted standards for quality assurance, safety, sustainability and environmental protection, and information security for a wide range of industries, including automotive, aerospace, food, health sciences, water, and forestry. Our client-focused teams have deep industry expertise and are committed to supporting the journey to certification by adding value at every stage, helping to empower organizations to drive process and performance improvements for products, people, and the planet.
