Quality Assurance Manager

Location

Benefits

Pulled from the full job description

Full job description

Introduction:

HelpWear is striving to achieve better at-home healthcare by developing affordable and accessible products for patients all around the world. We are seeking a dedicated Quality Assurance Manager to join our team. As the Quality Assurance Manager, you will be responsible for overseeing all aspects of HelpWear’s Quality Management System.

Roles and Responsibilities:

• Interpret, build upon, and comply with company quality assurance standards
• Carefully maintain complaint and non-conformance processing through records and tracking systems, including root cause and corrective actions
• Document quality assurance activities with internal reporting and audits
• Develop new standards for production and design, with improvements as needed, and create testing protocols for implementation across all service lines
• Identify training needs and take action to ensure company-wide compliance
• Pursue continuing education on new solutions, technology, and skills
• Plan, execute, and oversee inspection and testing of incoming and outgoing product to confirm quality conformance to specifications and quality deliverables
• Analyze and investigate product complaints or reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements
• Develop or update company complaint and inspection procedures to ensure capture and investigation, as well as proper documentation of complaints
• Monitor risk-management procedures, and maintain and analyze problem logs to identify and report recurring issues to management and product development
• Provide training and support to quality assurance team on systems, policies, procedures, and core processes
• Create quality measurement KPIs to track improvement in products
• Liaise with regulatory bodies with any issues concerning the QMS

Requirements:

• Bachelor's degree in a related field (e.g., Biomedical Engineering, Quality Management)
• Demonstrated knowledge of testing best practices, version control practices and defect management practice
• Thorough understanding of FDA regulations, ISO 13485, MDSAP, and other relevant international standards and regulatory requirements.
• Previous experience working in medical device companies
• Meticulous and diligent attributes
• Great team player with the ability to work independently
• Professional certification, such as Six Sigma, Quality Engineer, or Quality Auditor will be an asset, but not mandatory

Skills:

• Knowledge of quality assurance terminology, methods, and tools
• Superb computer competence
• Understanding how QA functions in the design process

Job Type: Full-time

Pay: $70,000.00-$95,000.00 per year

Benefits:

• Casual dress
• Dental care
• Extended health care
• Life insurance
• Vision care

Schedule:

• 8 hour shift
• Monday to Friday
• No weekends

Ability to commute/relocate:

• Toronto, ON: reliably commute or plan to relocate before starting work (preferred)

Education:

• Bachelor's Degree (preferred)

Experience:

• quality assurance: 3 years (preferred)
• ISO 13485: 1 year (preferred)

Work Location: In person