Auditor - Medical Devices, Quebec

Canadian Inclusion; Quebec; Hybrid; CAD 90,000 - 130,000; Full time

Job summary

Intertek seeks an Auditor for Medical Devices in Quebec. The role involves leading and/or participating in audits of client management systems under ISO 13485 and regulatory requirements, traveling to client sites, and mentoring junior auditors as needed.

You will review documentation, verify evidence, and present results to clients and certification boards. Extensive travel and strong communication skills are essential for success in this home-based position.

Qualifications

• In-depth knowledge of quality management systems in the medical device industry.
• Minimum 2 years in Quality or a controlled environment in medical device industry.
• 4-year college/university degree in a science or technical field or equivalent.

Responsibilities

• Audit client management systems for compliance with ISO 13485 and regulatory requirements.
• Lead Auditor or team member on audit engagements.
• Coordinate audit activity and liaise with clients.

Skills

Quality management systems

Lead Auditor experience

Communication skills

Travel willingness

Education

Science/technical degree

Job description

Auditor - Medical Devices, Quebec (Healthcare)

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 full timework experience in a medical device related industry. This will be a full-time/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.
• 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 and different Medical programprojects.
• Provide management with updates on status of work, initiatives, andprojects, as required.
• Travel will include overnight/multiple days, to various worksites andclient locations.

Qualifications

REQUIREMENTS:

• In-depth knowledge of qualitymanagement systems in the medicaldevice industry sector, demonstrated through a combination ofeducation and experience (minimum 2 years in Quality or controlled environment in medical device industry).
• 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 work experience in a medicaldevice or related industry.
• 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.

PREFERRED:

• Related 3rd party auditing industry management systemsexperience.
• Completed Lead Auditor training for any standard (preferably ISO13485), but will train if needed.
• Working/Training knowledge of relevant regulatory requirements for medicaldevices and pharmaceuticals in the EU, USA, Australia, Japan, Brazil,and/or Canada.
• Experience implementing/auditing to ISO 13485, ISO 14971, andmedical device and /or pharmaceuticalregulatoryrequirements.
• Specific experience/training on processes used in the relevantindustry's design, manufacturing, testing or clinical use(ex. sterilization, design and development of electro-mechanical or passivemedical device, plastic injection moldingorextrusion, training/experience in quality tools (Kaizen, lean manufacturing,etc.).
• Working experience in a wide range of medical devices is preferred.

PHYSICAL REQUIREMENTS:

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.

Salary & Benefits Information

When working with Intertek, you can expect salary and benefit package competitively placed within the local market, including medical, dental, vision, life, disability,Registered Retirement Savings Plan (RRSP)with company match, generous vacation/sick time (PTO),tuition reimbursement and more. Intertek employees are eligible for a variety of benefits including paid holidays.

Intertek's Commitment

Intertek 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.

Our Culture of Total Quality Assurance

Intertek promotes a culture where motivated, customer-oriented employeescan flourish, experience professional fulfillment, and reach their highest potential. At Intertek, we exercise our spirit of innovation, the passion of our people and our unmatched customer commitment to realize our purpose of making the world an ever better, safer, and more sustainable place for all.

A career with Intertek offers rewarding opportunities to help companies around the world develop products that are used safely by millions of people every day.Intertek is the trusted advisor to many of the world's leading brands, companies, and governments, and has earned a reputation for accuracy, reliability, integrity, and technical competence. Working at Intertek 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.

We Value Diversity

Intertek's network of phenomenal peopleare our greatest assets, and the diversity they bring fuels our success. Intertek is an Equal Employment Opportunity Employer that values inclusion and diversity. We take affirmative action to ensure all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, 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 [e-mail]

Bilingualism is needed for this role as the incumbent would need to deal with internal and external clients and employee's that work outside of Quebec.