QMS Contract Auditor – Medical Devices

Employer description

LNE/G-MED is an established 100-year old company that provides independent certification services, product testing and training for regulatory compliance and quality assurance worldwide. Due to rapid growth in our North American office, the company is seeking contract auditors who will perform audits and related assessments on its behalf in the following areas:

Certification of Quality Management Systems according to ISO Standards (according to ISO 9001, ISO 13485, etc.)
Certification for the CE Marking of Medical Device (all directives / all devices / all assessment modules)
Certification for access to the Canadian market
Inspection according to the US FDA Quality System Regulations

The permanent responsibilities of the contract auditors include, but are not limited to the following:

Performing audits (onsite, documentary) as auditor or lead auditor in the Medical Device sector with reference to:
- ISO 9001, ISO 13485 standards, …
- The European Directives on Medical Devices (MDD), Active Implantable Medical Devices (AIMD) and In Vitro Diagnostic Medical Devices (IVDD)
- ISO 13485 under the Canadian CMDCAS accreditation program.
Corresponding with the clients and LNE/G-MED team for the planning, performance and reporting in order to address, facilitate and satisfy our customers’ needs.

Interacting with LNE/G-MED Certification Project Managers, Experts, Production Manager, Quality Managers, and other team members in order to satisfy our accreditation/recognition and internal process criteria.

Job description

Education and Experience

Bachelor’s Degree in Technical or scientific area
A minimum and mandatory 4 years of experience in the medical field related to quality management; internal/external auditing or relevant work experience.
Preferably the candidate is already a qualified quality management system auditor for the medical device field.
Extensive technical knowledge associated with the Medical Device field (Sterilization, Biocompatibility, Electrical Medical Device Safety, etc.)
Extensive Regulatory Expertise (Worldwide regulations including Europe and Canadian)

Key Attributes

Strong organizational skills (demonstrated ability to prioritize and focus to meet deadlines)
Strong results-oriented and self-driven person
Ability to follow procedures and instruction
Excellent written and verbal communication skills, with ability to summarize technical content for specific audiences
Ability to understand, relate, and explain technical topics in a tactful manner
Ability to coordinate with a team
Open-minded, i.e; willing to consider alternative ideas or points of view
Self-reliant, i.e; acts and perform functions independently while interacting effectively with others,
Proficient in MS Office applications
Fluent in English

Added Preferences:

Ability to travel
Recent certified training or up-to-date on the different sterilization techniques and/or electromedical standards
Certified according to CMDCAS
Fluent in Spanish or Portuguese or French would be a plus

Compensation

This offer is for contract auditors paid per mission basis.

If you would like to join a dynamic organization, and are ready for a challenging and rewarding career, please submit your application (resume, cover letter, references, salary/rate history, and expectations) to hr@lne-gmed.com for consideration with the reference: Contract Auditor. Or fill in the form below.

For more information, please visit us at www.lne-america.com

This is an Equal Employment Opportunity

Principals only. Recruiters please don't contact this job poster.
Please, no phone calls about this job!
Please do not contact job poster about other services, products or commercial interests.

LNE/G-MED North America is an Equal Opportunity Employer