Lead Auditor
Intertek
Lachine, QC
Lead Auditor - (190001RG)
Description

The Auditor, Medical Devices will support the Business Assurance business by leading and/or participating as an assessor during all phases of a client’s management system, in accordance with the company’s accredited certification program. The Auditor is the primary interface with the client before and during the process of all 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. We’re looking for somebody with a minimum of 6-10 years of full-time work experience in a medical device related industry. Fluency in written and spoken English and French is a requirement.

This will be a full-time remote/home-based position, with extensive travel to client sites required.

Duties:
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 related to the medical device, pharmaceutical and/or cosmetic industry.

Assist clients with questions relevant to the audit and/or certification process.

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 team members. Make presentations to clients and/or certification board concerning audit results, when 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 continuous improvement.

Provide management with updates on status of work, initiatives, and projects, as required.

Travel will include overnight/multiple days, to various worksites and client locations.

Qualifications

Qualifications

Required:
Fluency in written and spoken English and French.

In-depth knowledge of auditing management systems in the medical device industry sector, demonstrated through a combination of education and experience:

Relevant formal education equivalent to a 4 year college/university degree in the U.S. (biology or microbiology; chemistry or biochemistry; computer and software technology; electrical, electronic, mechanical or bioengineering; human physiology; medicine; pharmacy; physics or biophysics).

A minimum of 6-10 years of full-time work experience in a medical device related industry.

Completed Lead Auditor training for any standard (preferably ISO 13485), but will train if needed.

Advanced coursework or training in quality management systems and/or relevant regulatory requirements.

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, but international travel may be needed (requires passport).

Preferred:
Related 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, pharmaceutical, and/or cosmetic regulatory requirements.

Specific experience/training on processes used in the relevant industry’s manufacturing (ex. sterilization).

Primary Location: CA-QC-Lachine
Work Locations: Lachine 32nd Avenue 1829 32nd Avenue Lachine H8T 3J1
Job: Auditing
Organization: CAN20:Intertek Testing Services NA Ltd
Schedule: Regular
Employee Status: Individual Contributor
Full-time
Job Level: First Shift
Travel: Yes, 75 % of the Time
Job Posting: Jul 16, 2019, 8:49:58 PM