The Auditor, Medical Devices will support the Business Assurancebusiness by leading and/or participating as an assessor during all phasesof a client's management system, in accordance with the company's accredited certification program. The Auditor is the primary interface withthe client before and during the process of all auditing activities.Additionally, the Auditor will help train low graded Auditors through witnessaudits, technical support, and education of both client and sales force asneeded. We're looking for somebody with a minimum of 6-10 years of fulltimework experience in a medical device related industry. This will be a full-time remote/home-based position, with extensive travel toclient sites required. DUTIES:
- Audit client management systems for compliance with establishedstandards, client, and/or industry requirements, governmentregulations, and other relevant standards, specifically ISO 13485,
- regulatory requirements for the US, Canada, Japan, Australia, and/orBrazil, and/or GMP regulatory requirements related to the medicaldevice, pharmaceutical and/or cosmetic industry.
- Assist clients with questions relevant to the audit and/or certificationprocess.
- Act as Lead Auditor or team member.
- 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 teammembers. Make presentations to clients and/or certification boardconcerning audit results, when required.
- Assist with corrective action requirements resulting fromassessments.
- Participate in audit meetings.
- Review audit reports and provide technical assistance to the medicalteam.
- Support management in areas of continuous improvement.
- Provide management with updates on status of work, initiatives, andprojects, as required.
- Travel will include overnight/multiple days, to various worksites andclient locations.
- In-depth knowledge of auditing management systems in the medicaldevice industry sector, demonstrated through a combination ofeducation and experience:
- 4 year college/university degree in a science or technical field(biology or microbiology; chemistry or biochemistry; computer andsoftware technology; electrical, electronic, mechanical or
- bioengineering; human physiology; medicine; pharmacy; physics orbiophysics) or equivalent combination of relevant education and workexperience.
- A minimum of 4+ years of full-time work experience in a medicaldevice or related industry.
- Completed Lead Auditor training for any standard (preferably ISO13485), but will train if needed.
- Training in quality management systems and/or relevant regulatoryrequirements.
- 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 drawvalid conclusions.
- Ability to exercise effective time management skills in completion ofassignments.
- Must be willing and able to travel extensively. Primarily domestictravel, some international travel may be needed.
- Related 3rd party auditing industry management systemsexperience.
- Working knowledge of relevant regulatory requirements for medicaldevices and pharmaceuticals in the EU, US, Australia, Japan, Brazil,and/or Canada.
- Experience implementing/auditing to ISO 13485, ISO 14971, andmedical device, pharmaceutical, and/or cosmetic regulatoryrequirements.
- Specific experience/training on processes used in the relevantindustry's manufacturing (ex. sterilization).Training/experience in quality tools (Kaizen, lean manufacturing,
- Working experience in a wide range of medical devices.
- This role requires the ability to:
- Ascend or descend ladders, stairs, ramps, and the like, using feetand 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 onework location to another.
- Communicate well, thru spoken word, conveying detailed accurateinformation & instructions to others.
- Hear well, perceiving sounds with or without correction, including theability to receive information thru oral communications.
- Exert up to 10 pounds of force occasionally and/or negligibleamounts of force frequently to lift, carry, push, pull or otherwise moveobjects.
- Have close visual acuity to perform an activity such as preparing &analyzing data, viewing a computer monitor, reading, report writing,visual inspection, and use of measurement devises.