Part Time Iso 13485 Auditor Jobs (NOW HIRING)

The Quality Assessments Division of Smithers seeks full-time and contract auditors to join our team to assess our clients to management system standards including Quality, Environmental, Occupational Health and Safety, Automotive, Aerospace, and Information Security. If you want to be a part of our mission to provide our clients with accurate data, on-time with high-touch, we would love to have you on board.

Smithers Quality Assessments is a global, accredited third-party Certification Body. Auditors perform assessments and certification activities to verify conformance to management system standards. Responsibilities include ensuring the certification scheme continuously meets the requirements of current industry standards, internal procedures and that of our accreditation requirements.  Your goal is to build positive relationships with our clients while providing quality auditing and exceptional client services while maintaining a high level of integrity and impartiality.

QMS/ EMS/ OHSMS Qualifications and/or Experience:

• For QMS, EMS or OHSMS auditors: 5 years of work experience with a minimum of two out of those 5 years in quality, environmental or occupational health & safety roles. ISO 9001 / 14001 / 45001 Lead Auditor Certification.

• Automotive and Aerospace sector auditors beyond this will be according to SQA qualification and competence requirements, per IATF Rules, and in accordance with ISO/IEC 17021, AS9104/3 and AS9104/1.

ISO 13485 Qualifications:

• Has gained experience in the entire process of auditing medical device quality management systems, including review of documentation and risk management of applicable medical devices, parts or services, implementation audit and audit reporting.
• Has gained experience by participating as a trainee in a minimum of four audits for a total of at least 20 days in an accredited QMS program, 50% of which shall be against ISO 13485 preferably in an accredited program, and the rest in any other accredited QMS program.

In addition to the criteria above, audit team leaders shall fulfill the following:

• Has experience as an audit team leader role under the supervision of a qualified team leader for at least three ISO 13485 audits.

IATF 16949 Qualifications include current 3rd party credentials:

• IATF 16949 Auditor credentials (third-party certification) accompanied by an IATF certificate number.

New IATF 16949 Auditor:

• Qualified to perform ISO 9001 Audits
• Conducted a minimum of six ISO 9001 third-party audits in manufacturing industries with at least three as audit team leader.
• Knowledge of automotive Core Tools (at a minimum: FMEA, MSA and SPC) – must have documented evidence of competency was achieved.
• Four years full-time appropriate practical experience (including two (2) years dedicated to Quality Assurance and/or Quality Management activities) within the past fifteen (15) years in an automotive manufacturing organization meeting the applicability of IATF 16949. (experience in similar industries may be considered)
• Observed a minimum of one (1) IATF third-party audit, excluding special audits, from beginning through the end, lasting a minimum of two (2) days.

AS 91XX Qualifications:

• All qualified auditors must have participated in a minimum of twenty (20) audit-days that cover all the elements of AS9100 standard spread over a minimum of four audit sites within the last 3 years.
• Work experience requirements preferred include four years in the aerospace industry directly involved in Engineering, Design, Manufacturing Quality or Process Control for a major airframe/spacecraft/space payload manufacturer, prime supplier, auxiliary equipment supplier and/or appropriate NASA, DOD, or FAA organization. In addition, personnel certification required per AS9104/3.

ISO 27001 Qualifications:

• Associate auditors - 5 years of work experience with a minimum of 2 years in cyber security implementation or auditing and either an (ISC)2 Entry Level Certification or Associate Membership.
• Auditors - 7 years of work experience with a minimum of 5 years in cyber security implementation or auditing and either a CISA, CISM, or ISO 27001 Certificate.
• Senior Auditors – 10 years of work experience with a minimum of 5 years in cyber security implementation or auditing and a CISSP with either a CISA or ISO 27001 Certificate.
• Auditor competency-based certificates should be demonstrated for support of auditor knowledge.
• Four (4) years of full-time appropriate practical experience (including two (2) years dedicated to Quality Assurance and/or Quality Management activities) within the past fifteen (15) years in an automotive manufacturing organization meeting the applicability of IATF 16949.