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, conduct/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
- Demonstrate effective teamwork, be respectful of others, maintain and communicate in a professional business-like manner
- Strong organizational skills
- Focused and capable of prioritizing workload, multi-tasking capabilities, ability to complete a variety of tasks while managing conflicting demands
- Motivated, self starter; able to work independently
- Problem solving skills and outside the box thinking for a variety of situations
- Knowledge of Microsoft Word, Intermediate to Advanced Excel skills, good working knowledge of Adobe Pro, Outlook, and PowerPoint
- Excellent written and oral communication skills
NOTE: This job description is not intended to be all-inclusive. Employee may perform other duties within the company
Job Type: Full-time
Salary: $65,155.00-$75,000.00 per year
Benefits:
- Dental care
- Extended health care
- On-site parking
- Paid time off
Schedule:
- 8 hour shift
- Monday to Friday
Supplemental pay types:
- Bonus pay
Language:
- English (required)
Work Location: In person
Application deadline: 2024-02-16