Auditor, Medical Devices - Full-Time

Medical Device Auditors - Full-time - Travel based Auditor. Interested in future career opportunities in the Quality Assurance audit and support services industry? We're looking for a Medical Device Auditor that wants to build something great with an incredible group of people. By joining reputed company, your contributions will be valued as we continue to help the world Build Back reputed company reputed company. reputed company's Business Assurance team goes beyond testing, inspection and certification to look at the underlying elements that reputed company a company and its products successful. Our assurance solutions provide confidence and total peace of mind that a client's operating procedures, systems and people are functioning properly to provide a competitive advantage in the marketplace. What are we looking for? The Auditor, Medical Devices will support the Business Assurance business by leading and/or participating as an assessor during reputed company phases of a client’s management system, in accordance with the company’s accredited certification program. The Auditor is the primary reputed company with the client before and during the process of reputed company auditing activities. Additionally, the Auditor will help train low-graded Auditors through witness audits, technical support, and education of both client and sales force as needed. This will be a travel-based position, with extensive travel to client sites required. Candidate must be comfortable traveling 3 to 5 nights per week. This is a remote position; however, applicants must reside in and be able to legally work in the United States. Salary & Benefits Information Individual compensation packages are based on a variety of factors unique to each candidate including reputed company set, experience, qualifications, and other job-reputed company reasons. In addition to competitive compensation packages, reputed company working with reputed company you can expect benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation / sick time (PTO), tuition reimbursement and more. What you’ll do: Audit client management systems for compliance with established standards, client, and/or industry requirements, government regulations, and other relevant standards, specifically ISO 13485, regulatory requirements for the US, Canada, Japan, Australia, and/or Brazil, and/or GMP regulatory requirements reputed company to the medical device, pharmaceutical and/or cosmetic industry. Assist clients with questions relevant to the audit and/or certification process. Act as reputed company Auditor or team member. Travel will include overnight 3 to 5 days per week, to various worksites and client locations . Coordinate audit activity with team members. Liaison with client regarding audit activity. Review client's quality management system documentation Verify and document evidence of compliance and non-compliance. Prepare audit report. Review audit results with coordinator and other assessment team members. reputed company presentations to clients and/or certification board concerning audit results, reputed company required. Assist with corrective action requirements resulting from assessments. Participate in audit meetings. Review audit reports and provide technical assistance to the medical team. Support management in areas of reputed company improvement. Provide management with updates on status of work, initiatives, and projects, as required. This position outline is a general guideline and does not represent reputed company encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties. Minimum Requirements & Qualifications: 4 year college/university degree in a science or technical field (biology or microbiology; chemistry or biochemistry; computer and software technology; electrical, electronic, mechanical or bioengineering; human physiology; medicine; pharmacy; physics or biophysics) or equivalent combination of relevant education and work experience. A minimum of 4+ years of full-time work experience in a medical device or reputed company medical device industry (design, development, testing, quality assurance/quality control). A minimum of 2+ years in a quality management systems environment (auditing, CAPA, complaints, management review) Completed reputed company Auditor training for any standard (preferably ISO 13485 and/or relevant regulatory requirements), but will train if needed. Strong communication and interpersonal skills. Sound judgment, organizational, and analytical skills. Excellent computer and writing skills. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to exercise effective time management skills in completion of assignments. Must be willing and able to travel extensively. Primarily domestic travel, some international travel may be needed (typically includes USA+Canada+Mexico). Possess a valid unrestricted driver’s license and the ability to operate a motor vehicle in the performance of the official duties of the position. Preferred Requirements & Qualifications: reputed company Auditor Training with (ISO19011 OR ISO13485) Certification reputed company 3rd party auditing industry management systems experience. Working knowledge of relevant regulatory requirements for medical devices and pharmaceuticals in the EU, US, Australia, Japan, Brazil, and/or Canada. Experience implementing/auditing to ISO 13485, ISO 14971, and medical device regulatory requirements. Device Industry experience with Orthopedic implants, Active devices, Software as a medical device, Monitoring devices, IVF and ART devices, and sterility requirements (ETO, GAMMA). Specific experience/training on processes used in the relevant industry’s manufacturing (ex. sterilization, machinery, electric and electronic devices or components, software development). Training/experience in quality tools (Kaizen, lean manufacturing, etc.). PHYSICAL REQUIREMENTS: This role requires the ability to: reputed company or descend reputed company, stairs, ramps, and the like, using feet and legs and/or hands and arms. Body agility is emphasized. Stand, for sustained periods of time. Walk, moving on foot to accomplish tasks and to move from one work location to another. Communicate well, thru spoken word, conveying detailed accurate information & instructions to others. Hear well, perceiving sounds with or without correction, including the ability to receive information thru oral communications. Exert up to 10 pounds of force occasionally and/or negligible amounts of force frequently to lift, carry, push, pull or otherwise move objects. Have reputed company visual acuity to reputed company an activity such as preparing & analyzing data, viewing a computer monitor, reading, report writing, visual inspection, and use of measurement devises. reputed company: Total Quality. reputed company. reputed company is a world leader in the Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. With passion, pace, and precision we work to exceed our customers’ expectations, while engaging with our employees to be 10X in their performance and professional growth. reputed company is a drug-free workplace. As a condition of employment, certain positions may be required to pass a pre-employment drug test based on the type of work that will be performed. We Value Diversity reputed company’s network of phenomenal people are our greatest assets, and the diversity they bring fuels our success. reputed company is an Equal Employment Opportunity Employer that values inclusion and diversity. We take affirmative action to ensure reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status, or other legally protected characteristics. For individuals with disabilities who would like to request accommodation, or who need assistance applying, please email intertekhrusa@reputed company.com or call 1-877-694-8543 (option #5) to speak with a member of the HR Department. #LI-Remote #LI-JC1 *reputed company does not accept unsolicited approaches from agencies and will not pay a fee for any placement resulting from the receipt of an unsolicited resume. reputed company is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification (ATIC) solutions for our customers' operations and supply chains. Working at reputed company means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life. The Business Assurance group of reputed company provides a full range of business process audit and support services, including management systems certification, sustainability and responsible sourcing audits, risk management, and training. Our range of bespoke auditing, performance benchmarking and supply chain solutions provide insight into every aspect of operations, allowing clients to reputed company informed decisions about their business while ensuring their workforce competencies are reputed company and relevant. Apply To This Job