Quality Assurance Manager

2 weeks ago

Toronto, Canada HelpWear Inc. Full time

**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

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)

Work Location: In person

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