Medical Device Qms Consultant

About the company

Isometric management systems consulting supports firms in implementing management systems that adhere to international standards and relevant regulatory requirements, and, as such, we’re constantly developing innovative tools to make the implementation and auditing of management systems as effective and efficient as possible.

About the role

The medical device QMS consultant will support our medical device client in implementing and improving their ISO 13485 QMS, work within the confines of ISO 13485:2016 QMS to support the delivery of the desired medical device, and also work with the OEM to develop the product-specific procedures for our client. The ideal consultant should be able to work with little or no supervision.

Responsibilities

• Gap assessments.
• Coordination with OEM.
• Internal audit support
• Create the SOPs to support the activities for sales, import, distribution, etc. of the device.
• QMS document creation.
• Coach the client on general quality management principles.
• Prepare DHf and biocompatibility studies.
• Record creation.
• Managing CAPA resolutions
• Support the closure of internal and registrar audit findings.

Qualifications and experience

• 5–10 years of experience implementing and auditing medical device management systems
• A B.Sc. or Master's degree is desired.
• ISO 13485:2016 certifications are required.

Contract Duration

1 - 2 Months

Location

• Michigan
• Kitchener, ON

Join a team of leading consultants.

Isometric credits much of its success to the commitment and competence of our diverse consultants. We are an equal opportunity employer, and we afford equal opportunity to all applicants and employees for all positions without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other status protected under local, state, or federal laws.