Compensation for contractors will be based on industry standard for professionals with the requisite expertise and experience as well as rates negotiated with customers.
4 Year Degree
Telecommuting is allowed.
Internal Number: 1001
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.
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)
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.
AJW Technology Consultants, Inc. was established in 1999. Since its founding, the organization has developed a client base of nearly 750 companies from around the globe. We offer a wide range of services to the medical device, pharmaceutical and biologics industries. We center our core business on quality and regulatory compliance activities for medical devices and focus is on building mutually beneficial client relationships, resulting continuous growth over the years from word-of-mouth referrals.
Besides it’s full-time employees, AJW Technology Consultants and its affiliates utilize a network of over 30 industry experts and their respective organizations in order to fulfill our customer’s’ individual project requirements. In 2013, the holding company known as PharmaMed Global, LLC (PMG) acquire AJW Technology Consultants, Inc. At that time, Jon Ward was the owner and operator of PMG. It has also acquired or established several related consulting firms in an effort to provide a global footprint and to meet the growing needs of its clients.
What we are Today
Today, we have offices in the US, Australia, New Zealand, Germany, Switzerland, and the United Kingdom. Our objective... is to provide in-country representation and regulatory agency submissions. Additionally we have ‘Channel Partners’ providing similar services in Latin America and Asia. While quality and regulatory compliance are still a significant part of the business. Extensive internal expertise is supplementing by a solid network of diverse subject matter experts. Which enables our team to provide a full suite of development and commercialization services to clients. We provide alignment between the numerous strategic planning and operational activities required prior to, during, and following product launch.
Our expertise supports the product life cycle and covers activities ranging from ‘Early Development’ (product concept and pitch development, investor relations, design engineering, clinical testing, regulatory strategy, quality systems, due diligence) to ‘Late Stage Support’ (contract manufacturing, marketing intelligence, reimbursement strategy, clinical studies, and distribution).