Medical Device Coordinator jobs

Quality Associate

With more than 30 years as a Canadian Medical Distributor, Associated Health Systems Inc specializes in products pertaining to Falls Reduction and Injury Prevention, OR efficiencies, Hospital Storage and Education Lab Skills Kits.

Associated Health Systems Inc. brings established product, and product solutions that we are continuously developing, to the healthcare market of Acute Care Hospitals, Private Surgery and Long-Term Care Centres.

Our Commitment:
Associated Health Systems Inc. strives to be recognized as an innovator: both in the types of products represented and developed, and in the methods of service delivery to our customers and supplier partners.

We are committed to continually striving to achieve excellence in quality and innovation, complying with and maintaining the effectiveness of our Quality Management System, and preserving a strong and competitive economic advantage.

The Opportunity:

This position offers the opportunity to engage in the continuously evolving and intriguing medical device sector through a very robust Quality Management System.

The Quality Associate will be based in the Edmonton, AB office. It is a team approach to maintaining and evolving the quality system and a resource for the Company. The critical job function of this role requires attention to detail, time management and overall awareness the importance of the Quality System to the business

Description of Role:

Quality/ISO Functions

• One of the Quality representatives for internal and annual ISO audits, under the direct lead of the Quality and Regulatory Manager
• Responsible for participating in ISO audits
• Provide training and share knowledge on Quality procedures & processes
• Ensure ISO license is up to date
• Knowledgeable with the Health Canada website to source medical device license classes MDALL
• Initiate/oversee complaints, non-conformances, change control and CAPA reporting and completion of required documents
• Review Return Material Authorizations (RMA), review cause and close RMA documents
• Ensure ISO/Quality standards are met and incorporated into daily job functions
• Update quality procedures and processes, when necessary, in conjunction with Quality and Regulatory Manager.

Other Job Functions

• Follow proper processes with Health Canada in regards to requests for additional medical device licenses, recall process and any other related process related to the Quality System
• Regular review of ISO standards and Medical Device Regulations, to ensure up to date version utilized

Other

• Attend, participate in staff meetings
• Travel as required

Skills/Abilities

• Experience in working within a Quality Management team
• Experience working with Health Canada and Medical background preferred
• Exceptional communication skills
• Strong organizational skills
• Thrives in both autonomous and collaborative settings
• Focused and capable of prioritizing workload, multi-tasking capabilities, ability to complete a variety of tasks while managing conflicting demands
• Problem solving skills and outside the box thinking for a variety of situations
• Knowledge of Microsoft Word, Excel, Outlook, and PowerPoint with excellent written and oral communication.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other duties within the company

Job Type: Full-time

Pay: $65,000.00-$75,000.00 per year

Benefits:

• Dental care
• Extended health care
• On-site parking
• Paid time off

Ability to commute/relocate:

• Edmonton, AB T5S 2Y2: reliably commute or plan to relocate before starting work (required)

Language:

• English (required)

Work Location: Hybrid remote in Edmonton, AB T5S 2Y2