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Quality Assurance Associate
3 weeks ago
The Quality Assurance (QA) Associate, under the direction of the Associate Manager, QMS will support the implementation and maintenance of the Quality Management System (QMS) and Document Management System (DMS), participate in quality improvement initiatives, and the development of policies, procedures, and education materials to support the business. The incumbent will support the assigned business lines with Quality Events, Risk Management, Privacy Management as well as Internal and External Audit Program. Occasionally this position may provide support to other business lines as deemed appropriate by the Quality Management team.
This position is permanent full-time, hybrid with once a week on-site work at 233 Alden Road, Markham, ON, L3R 3W6.
**DUTIES AND RESPONSIBILITIES**
- Participates in the development, implementation and maintenance of Quality Management System and Document Management System.
- Ensure processes meet established quality standards and follow all applicable regulatory and legislative requirements and are version controlled via the document change control process.
- Conducts Policy, SOP and WI reviews and revisions, participates in the development of new policies, procedures, and SOPs, and performs their efficacy analysis. Helps ensure appropriate training assignment on rolled-out policies, procedures, and SOPs including appropriate communication to all employees.
- Supports management of quality events (deviations). Conducts root cause analysis, investigations and ensures CAPA plan is effective and closes on time. This will require education, coordination, and collaboration across the team with all internal stakeholders. Assists with quality event trends analysis and resulting improvement initiatives.
- Supports internal audit program and spot audits as required to ensure compliance.
- Identifies training needs, participates in the development of training materials, and leads training to meet quality management standards and contractual requirements.
- Educates internal stakeholders on key quality deliverables and identifies process improvements to increase efficiency, effectiveness, and quality.
- Liaises with Quality leads from other business lines to collaborate on initiatives or adapt mutually beneficial processes.
- Performs other duties as assigned.
Job Qualification
**What You Bring to the Team**
- Bachelor’s degree preferably in a health-related field.
- ASQ Quality certification, ISO Auditor Certification, or equivalent quality certification will be considered an asset.
- Completion of Quality Management, Risk Management, or related courses is preferable.
- At least 3 years of experience in quality assurance, preferably in healthcare or life sciences industry.
- Experience in the development of policies, SOPs and WIs.
- Experience in managing deviations, RCA, and CAPA plan.
- Understanding QMS Validation is an asset.
- Previous experience working with Health Canada on the medical device establishments would be preferred.
- Strong interpersonal skills and ability to work independently and as part of a team.
- Proven ability to build consensus and lead new initiatives.
- Demonstrated ability and competency in Windows software.
- Exceptional organizational skills, and ability to meet deadlines.
- Strong commitment to continual learning.
- Ability to grasp the essence of issues, deal comfortably with ambiguity, and make high-quality decisions quickly.
“At Bayshore Healthcare, our commitment to Equity, Diversity & Inclusion is our strength. This is how we bring our vision of being the difference in the lives of those we care for, work with and in our communities. We have a great sense of pride in creating a culture of belonging, where individual differences are embraced and celebrated, through programs, resources and policies that support each individuals purpose, potential and wellbeing.”
Bayshore operates in accordance with the Accessibility for Ontarians with Disabilities Act, and applicable Provincial Human Rights Codes.
