Healthcare QA Specialist

Overview

As a Healthcare QA Specialist, you will play a pivotal role in ensuring the highest standards of quality and compliance within our healthcare manufacturing processes. Your expertise will help us uphold regulatory requirements and maintain exceptional quality systems. You'll collaborate with cross-functional teams to implement and monitor quality assurance protocols, ensuring that our products meet both internal and external standards. If you are passionate about quality management and eager to make a difference in the healthcare sector, this is the perfect opportunity for you

What you'll do

• Develop, implement, and maintain quality assurance processes in accordance with FDA regulations and ISO standards such as ISO 13485 and ISO 9001.
• Conduct thorough quality audits to ensure compliance with CGMP (Current Good Manufacturing Practices) and HACCP (Hazard Analysis Critical Control Point) principles.
• Utilize precision measuring instruments including calipers, micrometers, and coordinate measuring machines to perform quality inspections.
• Analyze data collected from various quality control measures to identify trends and areas for improvement.
• Collaborate with manufacturing teams to address quality issues promptly and effectively, fostering a culture of continuous improvement.
• Oversee the implementation of vision inspection systems to enhance product quality assessments.
• Prepare detailed reports on quality metrics, audit findings, and corrective actions taken to ensure transparency and accountability.

Basic qualifications

• Strong analytical skills with a keen eye for detail in data collection and analysis.
• Proficiency in QA/QC methodologies and experience with quality management systems.

Preferred qualifications

• Familiarity with Calypso software for measurement data management.
• Experience conducting quality inspections within a healthcare or manufacturing environment.
• Knowledge of industry regulations including FDA guidelines and ISO standards.

SereneAid – Candidate Experience Summary

Total Years of Experience:

8+ Years

Healthcare Domain Experience:

Electronic Health Records (EHR), Issuer/Claims Applications, Patient Data Security, Clinical Systems

SereneAid – Detailed Job Description

(Roles & Responsibilities – Healthcare QA Specialist)

The Senior QA Specialist will support SereneAid's healthcare technology and clinical-systems clients by testing mission-critical issuer and patient-care applications. This role ensures software solutions meet functional, performance, reliability, and interoperability standards required under PHIPA/HIPAA regulatory frameworks.

Core Responsibilities:

• Lead and execute QA activities across healthcare product release cycles (Sprints & Major Releases).
• Interpret clinical and operational business workflows; translate requirements into traceable test scripts.
• Design, document, review, and execute functional, integration, regression, and data-validation tests for highly regulated healthcare systems.
• Ensure compliance with PHIPA/HIPAA, privacy, and patient-data protection controls throughout the QA lifecycle.
• Maintain robust defect management practices; log, track, and coordinate root-cause resolution with development teams.
• Support UAT processes, coordinating sign-offs with providers, care coordinators, and business owners.
• Build test summary reports and KPIs and communicate technical results to leadership and clinical ops.
• Mentor junior QA team members in healthcare system testing, automation execution, and documentation.
• Recommend tools, process improvements, and automation opportunities to enhance delivery efficiency.

Mandatory Skills

• Strong hands-on QA expertise in regulated healthcare systems
• Team guidance, peer review, and quality ownership
• API testing, backend data validation, and workflow-driven scenario creation
• Strong written and verbal communication to support clinical stakeholders

Desired Skills

• Understanding of HL7/FHIR standards, Medical Claims Processing, EMR/EHR flows
• Familiarity with performance testing for clinical system scalability
• Contribution to automation roadmap and tool enhancements

Domain

• Healthcare & Patient Informatics

(EHR systems, Claims Issuer applications, Patient care software)

Work Location

Client Site – Mississauga, Ontario (SereneAid Healthcare Client)

(Onsite engagement as per client security requirements)

Background Screening Requirements

• Client-specific pre-employment BGV
• Healthcare compliance screening may include:
• Immunization & vaccination clearance
• Vulnerable sector check
• PHIPA/HIPAA confidentiality acknowledgment

Shift Requirement

• Standard Daylight Business Hours
• Additional hours only upon client request (advanced notice required)

Job Type: Permanent

Pay: $41,741.00-$74,284.32 per year

Work Location: In person