As a seasoned, experienced professional, you will support the organization with maintaining compliance and conformance to our established quality assurance processes, regulatory requirements, and standards for manufacturing and operations. More specifically, you will perform evaluation of internal controls, communications, risk assessments, and maintenance of documentation while working cross functionally to appropriately remedy deficiencies. You will also manage validations, verifications, requalifications and create and manage operational FMEAs. Facilitating internal training on quality assurance requirements, processes, and procedures will also be managed by you. There may also be opportunity to perform/participate in internal, external, and supplier audits. Typically to succeed in this role, you should have a post-secondary degree and at least 5 years of comparable work experience. A combination of education and experience will be considered. The ability to work both independently and as part of a team on multiple assignments and projects in a highly customer focused environment is essential. Conflict resolution skills and the ability to manage stressful situations, as well as proficiency on Microsoft Office is required. You should have expert knowledge of the quality assurance system, including Quality System Regulation US FDA 21 CFR part 820 and ISO 13485 standard. Experience working in a regulated environment and familiarity with ISO 13485, ISO 9001, Canadian, U.S. FDA and European in vitro diagnostic medical device regulatory requirements would be preferred. The anticipated base salary for this position is $65,000 - $72,000. This role may also qualify for annual incentives and/or comprehensive benefits. The actual base salary offered will depend on a variety of factors, including without limitation, the qualifications of the individual applicant for the position, years of relevant experience, level of education attained, certifications or other professional licenses held, and if applicable, the location of the position. If this sounds like the role for you and you can lift and carry up to 20lbs, please apply for immediate consideration! About us: At Sekisui Diagnostics, we help improve patient outcomes by doing what we\'ve always done - focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers - and customize solutions at both a regional and product level. Sekisui Diagnostics offers a competitive compensation and benefits package including a generous hourly rate, participation in annual bonus plan, Company match to RRSP, education and fitness reimbursements and paid time off to volunteer. Equal Opportunities As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job-related characteristics or other prohibited grounds specified in applicable country and local laws. It is also Sekisui Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions. Sekisui Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the Company\xe2\x80\x99s internal recruiting team.