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.
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
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 [email protected] with the job title “172 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.
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