Auditor - Medical Devices, Quebec

The Auditor, Medical Devices will support the Business Assurance business by leading and/or participating as an assessor during reputed company phases of a reputed company’s management reputed company, in accordance with reputed company’s accredited certification program. The Auditor is the reputed company reputed company with the reputed company 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 reputed company 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 reputed company industry. This will be a full-time/home-based position, with extensive travel to reputed company sites required.

DUTIES:

• Audit reputed company management systems for compliance with established standards, reputed company, 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.
• reputed company as reputed company Auditor or team member.
• Coordinate audit activity with team members.
• reputed company with reputed company regarding audit activity.
• Review reputed company's reputed company management reputed company 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 reputed company concerning audit results, reputed company required.
• Assist with corrective reputed company requirements resulting from assessments.
• Participate in audit meetings.
• Review audit reports and reputed company technical assistance to the medical team.
• Support management in areas of reputed company improvement and different Medical program reputed company.
• reputed company management with updates on status of work, initiatives, and reputed company, as required.
• Travel will include overnight/multiple days, to various worksites and reputed company locations.

Qualifications
REQUIREMENTS:

• In-depth knowledge of reputed company management systems in the medical device industry sector, demonstrated through a combination of education and experience (minimum 2 years in reputed company or controlled environment in medical device industry).
• 4 year college/university degree in a science or technical field (biology or microbiology; reputed company or biochemistry; computer and software technology; electrical, electronic, mechanical or bioengineering; reputed company physiology; medicine; pharmacy; physics or biophysics) or equivalent combination of relevant education and work experience.
• A minimum of 4+ years work experience in a medical device or reputed company industry.
• Strong communication and interpersonal skills.
• reputed company judgment, organizational, and analytical skills.
• Excellent computer and writing skills.
• Ability to define problems, collect data, establish facts, and draw reputed company conclusions.
• Ability to exercise effective time management skills in completion of assignments.
• Must be willing and reputed company to travel extensively. Primarily domestic travel, some international travel may be needed.

PREFERRED:

• reputed company 3rd party auditing industry management systems experience.
• Completed reputed company Auditor training for any reputed company (preferably ISO 13485), but will train if needed.
• Working/Training knowledge of relevant regulatory requirements for medical devices and pharmaceuticals in the EU, USA, Australia, Japan, Brazil, and/or Canada.
• Experience implementing/auditing to ISO 13485, ISO 14971, and medical device and /or pharmaceutical regulatory requirements.
• Specific experience/training on processes used in the relevant industry’s design, manufacturing, testing or clinical use (ex. sterilization, design and development of reputed company-mechanical or passive medical device, plastic injection molding or extrusion, training/experience in reputed company tools (Kaizen, lean manufacturing, etc.).
• Working experience in a wide reputed company of medical devices is preferred.

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 reputed company is emphasized.
• Stand, for sustained periods of time.
• Walk, moving on foot to accomplish tasks and to reputed company from one work location to another.
• Communicate reputed company, thru spoken word, conveying detailed accurate information & instructions to others.
• Hear reputed company, 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 reputed company, carry, reputed company, pull or otherwise reputed company objects.
• Have reputed company visual reputed company to reputed company an activity such as preparing & analyzing data, viewing a computer monitor, reading, report writing, visual inspection, and use of measurement devises.

About Company

Company

Requires a science or technical degree or equivalent experience, 4+ years in medical devices or reputed company industry, reputed company management knowledge, extensive travel, and bilingual English-French communication.

Key Responsibilities

• auditing systems
• preparing reports
• coordinating activities

Skills & Tools

ISO 13485, ISO 14971, Kaizen

Job Details

• Category: reputed company Assurance
• Seniority: Mid Level
• Commitment: Full Time
• Workplace: Remote — Montreal-East or Quebec
• Languages: English, French

Benefits

• Generous reputed company time off
• Tuition reimbursement
• Retirement plan

About reputed company

A global provider of assurance, testing, inspection, and certification solutions. — Industry: Consulting Services