Careers
Kardium is a technology pioneer developing devices to address cardiovascular diseases. The company was founded in 2007 by a team with a track record of excellence in medicine, business, and engineering. Focused on building a world-class, internationally dominant medical device company, we believe in having lots of fun while working hard. We hire top individuals who are strong team players and trust them to make the right decisions to achieve our goals. We expect to grow significantly in size over the next several years and are always interested in hearing from intelligent, enthusiastic, hard-working, entrepreneurial people. Kardium offers a flexible work environment, a comprehensive salary and benefits program and the ability to participate in equity through a stock option plan. If you would like to:
- Work in a start up environment and currently have experience in mechanical, software or medical engineering, medical trials, or product management, contact at us at jobs@kardium.com.
- Receive an email update when new job openings are posted, send an email to jobs@kardium.com with the subject line with the subject line “Subscribe to new job postings”.
Kardium is located in Vancouver, Canada. Vancouver, home of the 2010 Winter Olympic and Paralympic Games, is a vibrant and diverse urban center surrounded by abundant natural attractions. The city is internationally ranked as one of the ‘Best Places To Live’ by the Mercer Consulting Quality of Living Survey.
Current Opportunities
QA/QC Technician Kardium has a unique opportunity for an experienced QA/QC Technician. As a member of the Quality Assurance team, the successful candidate will provide Quality Assurance support to manufacturing operations. The role may also assist with Quality Control tasks. This position will report to the QA Operations Manager. Responsibilities:
- Supporting daily QMS operations, including QA document and record compilation, review, filing and maintenance.
- Assisting with authoring, revising and/or reviewing Standard Operating Procedures and other QMS documents.
- Initiating and following up on Nonconformity Reports (NCR’s), Corrective and Preventive Actions (CAPA’s), and Supplier Corrective Actions Reports (SCAR’s).
- Assisting with document and record review for root cause investigations in collaboration with Engineering and Manufacturing.
- Assisting with internal audits and data compilation for trending analysis.
- Compiling and reviewing Device History Records (DHR’s) for completeness and accuracy to support product release.
- Interacting with internal parties to resolve quality issues.
- Assisting with the administration and expansion of the company’s Electronic Document and Record Control System.
- Performing various document and record control activities (e.g., logging, filing, distribution control, etc.).
- Performing incoming material inspection, in-process inspection, and final inspection to procedures, specifications, Maintaining material status identification throughout the production cycle.
- Maintaining material status identification throughout the production cycle.
- Documenting and escalating inspection results and failures.
Education and Experience:
- Must have a minimum of 3 years of Quality Assurance and Quality Control experience in the Biotech field, or an equivalent combination of education, technical training and/or related experience.
- Good understanding of ISO 13485:2003, 21 CFR Part 820 Quality System Regulation, and/or GMP is required.
Skills:
- Effective written & verbal communication and technical documentation skills.
- Inquisitive nature and strong analytical thinking.
- Ability to read, appropriately interpret and follow detailed inspection procedures and work instructions, and to document inspection accurately.
- Familiar with test equipment basics.
- Flexible and adaptable to take on additional responsibilities as appropriate.
To apply for this position, please send a résumé and cover letter to jobs@kardium.com, with the job title “QA/QC Technician” in the subject line.
