244 Compliance Specialist

Kardium has a unique opportunity for a Compliance Specialist. As a member of the Quality Assurance (QA) Team, the Compliance Specialist will provide support to the maintenance of Kardium’s Quality Management System (QMS). The position reports to the Compliance Manager.

Responsibilities

Leads QMS expansion and improvement projects, and any other tasks required to maintain QMS and product compliance, including assistance with the development and delivery of QMS training

Assists with development and assessment of QMS performance metrics

Assists with external audits and regulatory inspections

Acts as a member of the internal audit team performing audits of the QMS system, including assisting with planning, preparing reports, and other audit documentation, and performing follow-up activities

Performs supplier qualification, monitoring and part certification activities, including site audits

Assists with the maintenance of the company’s regulatory list of external standards

Performs assessment of investigations, corrective and preventative actions, and effectiveness checks, as needed.

Performs any other QA tasks as required

Education and Experience

Bachelor degree, preferably in a technical/science field, or equivalent combination of education and experience

Three to five years’ QA experience in a manufacturing environment

Strong working knowledge of ISO 13485 and FDA QSR or ISO9001 in a regulated industry

Experience with electronic document and electronic record management systems

Previous experience in auditing techniques desirable

Skills

  • Strong analytical skills and critical thinking
  • Effective written and verbal communication and technical documentation skills
  • Strong computer skills (MS Office, Access, Excel)
  • Organized and detail-oriented
  • Excellent interpersonal skills
  • Willingness to travel occasionally
  • Flexible and adaptable to take on additional responsibilities as appropriate

How to Apply

To apply for this position, please send a résumé and cover letter to jobs@kardium.com with the job title “244 Compliance Specialist” in the subject line.

Please note: only candidates who are currently legally authorized to work in Canada will be considered for this position.

Thanks in advance for your interest in working at Kardium.

To apply for this job email your details to jobs@kardium.com