Job Description

Company Description

Improving healthcare through innovative technology is at the core of Intelerad\'s work. Our scalable medical imaging platform connects clinicians to a powerful imaging ecosystem that is fast, smart, and tapped into the data they need, no matter their location. We\'re focused on delivering a best-in-class medical image management solution that improves provider efficiency, decreases the cost of healthcare, and improves the overall health of populations.

Intelerad offers one of healthcare\'s most comprehensive imaging and analytics platforms. Headquartered in Raleigh, NC and Montreal, Intelerad has nearly 700 employees located in offices across six countries. The company empowers nearly 2,000 healthcare organizations around the world with the speed, scalability, and simplicity needed to increase business performance while, most importantly, improving patient outcomes. Intelerad\'s modern enterprise solutions have been acknowledged by a Best in KLAS recognition, ranking #1 for PACS Asia/Oceania in the 2021 Best in KLAS: Global Software (Non-US) report. To learn more, visit and follow Intelerad on LinkedIn and Twitter.



Role:

The QMS specialist works within the regulatory affairs department. He/she participates in improving and maintaining certifications such as ISO 13485, MDSAP and CE mark as well as other standards and applicable laws.

The QMS Specialist also works with the various process owners to ensure regulations requirements are integrated into followed processes and procedures while improving our current management system. This position provides guidance, support and training to the rest of the organization.

Responsibilities:

Management of the QMS

Ensure management of Corrective and preventative actions (CAPAs): issue, assign, verify implementation and effectiveness within set timeframes.

Ensure maintenance of the QMS documentation and proper retention of documents and records.

Participate in activities related to adverse events and recalls (reports, notification, follow-ups)

Supervise and coordinate external QMS audits.

Conduct and/or coordinate QMS internal audits to ensure compliance to legal, regulatory and ISO standards requirements.

Provide advice and take action, where necessary, in response to audit findings and recommendations in respect of QMS.

Oversee and participate in the creation of QMS training material and provide such training when required.

Participate in Quality meetings as needed, including the setting of new metrics and ensuring existing metrics are gathered, analyzed and acted upon.

Improve the QMS

Create, update, and/or review QMS documents, in collaboration with process owners.

Analyse and find solutions to improve our QMS efficiency

Coordinate and participate in internal process improvement projects

Work on special projects with regard to the organization\'s orientations (reports, statistics, research, etc.).

Collaborate with the process owners to integrate new regulations requirements into current processes.

Participate in other projects deemed necessary by Intelerad

Qualifications

3+ years experience in quality management system(s)

Bachelor degree in business, quality management or related fields

Knowledge of ISO 9001, and/or ISO 13485, MDSAP and EMDR requirements.

Knowledge of MS Office, Google Suite and Visio (or similar workflow tool)

Strong verbal and written communication skills in English

Desired:

• Process mapping and creation
• Autonomous
• Great collaborator
• Problem-solver
• Learning skills
• Communication skills
• Experience in the IT and/or medical device field

Additional Information

All applicants meeting minimum qualifications will be required to complete a 30 minute online assessment as part of your application.

Intelerad is committed to the principles of equal employment. We are committed to complying with all federal, state and local laws providing equal employment opportunities and all other employment laws and regulations. Applicants, employees and former employees are protected from employment discrimination based on race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age (40 or older), disability and genetic information (including family medical history). Intelerad is dedicated to the fulfillment of this policy regarding all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay, and other compensation, termination, and all other terms, conditions, and privileges of employment.

Intelerad is committed to ensuring equal employment opportunity for qualified individuals with disabilities. Intelerad uses the Americans with Disabilities Act (\xe2\x80\x9cADA\xe2\x80\x9d)as a standard for global recruiting and hiring purposes. This prohibits discrimination against qualified individuals with disabilities. The ADA defines \xe2\x80\x9cdisability\xe2\x80\x9d as a physical or mental impairment that substantially limits one or more of the major life activities of an individual, a record of such impairment, or being regarded as having such an impairment.

Meet Intelerad\'s Leadership Team:

#LI-remote

Intelerad