About Us:

AJW Technology Consultants, Inc. is a regulatory and quality management consulting firm established in 1999. While our home base is out of the Tampa Bay area of Florida, we have offices around the globe, including Australia, New Zealand, Germany, Switzerland, and the UK. We provide end-to-end consulting solutions for medical device manufacturers. We are agile and adaptable in customizing our service offerings for our customers based on the stage of development or product life cycle and their individual project requirements. One of our steady and growing service offerings is performing independent internal audits for our medical device and IVD manufacturer customers. The demand for our auditing services has increased over the years and we are now looking to add to our team of auditors as we strive to meet and exceed our customers’ expectations.

Job Summary:

We are seeking a key member(s) of the auditing team involved in the auditing of various medical device and IVD manufacturing sites for our customers. Internal auditing and supplier auditing, as a service, goes beyond simply observing and recording levels of conformity to audit criteria. Our customers expect us to deliver value and provide a learning experience for their staff. We strive to provide an enjoyable audit environment. Audits can be challenging when someone else is scrutinizing your work and while we do not avoid or dismiss discussions regarding potential deficiencies, we make every effort to remain personable, flexible, and relatable. We have found our customers, and their suppliers, to be very receptive to this approach and they keep asking for us to come back. That is where you fit in. We are looking for additional contract auditor(s) to represent our company and deliver high-value internal and supplier audits.

Primary Duties and Responsibilities:

• Develop audit plans, conduct quality management system audits, prepare audit reports and communicate findings, including compliance risk
• Documenting observations and recommendations for improvement utilizing AJW Tech templates
• Review and evaluate prior internal audit deficiency responses against corrective action plans, current industry standards, regulations and guidelines to assure compliance
• Verify closure of prior audit corrective and preventative actions to ensure implementation, compliance and continuing efficacy
• Preparing and presenting audit summaries and reports to auditee within specified timeframes (as per auditee procedure or AJW Tech policy, as applicable)
• Keeping abreast of industry standards and regulations
• Must display in-depth understanding of FDA, MDSAP, and EU regulations. Must be able to demonstrate advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations
• Open to a flexible and fluid work environment
• Available to travel to customer sites

Experience and Education:

• Bachelor’s degree in a chemical, physical, biological or clinical laboratory science, or biomedical engineering from an accredited institution
• Must have at least 5 years of experience in medical device and/or IVD quality system audits including both internal and supplier auditing
• Objective evidence of training and/or certification to the following regulatory requirements:

• 21 CFR 820
• 21 CFR 803
• 21 CFR 806
• 21 CFR Part 11
• 21 CFR 600, 610
• 21 CFR 200, 210
• MDSAP (including country specific requirements for US, Brazil, Australia, Japan, and Canada)
• EU MDR
• EU IVDR
• ISO 13485:2016
• ISO 14971:2019

• Exceptional attention to detail
• Excellent leadership and communication skills
• Advanced organizational skills
• Personal computer skills (e.g., Microsoft Word, Excel, SharePoint, etc)
• Must be able to communicate effectively, both verbally and in writing, with all levels of personnel

This is a remote, contract position, however, full-time position may become available.