Quality Assurance Specialist

The Quality Assurance Lead’s responsibilities include ensuring excellent quality service is provided to all Rapid Aid customers and internal departments. This position will work closely with customers and internal departments to ensure the efficient coordination and communication of information in order to enhance the level of quality throughout the Rapid Aid organization. The Quality Assurance Lead will work to ensure that best practices are in place for the research, development and testing of all new products. The Quality Assurance Lead is responsible for spearheading Quality Management System and regulatory compliance with the Food and Drug Administration and Health Canada regulations.

**Reports To**:Director, Packaging Engineering and Validation

**Reporting Departments**:Quality

**Direct Report**:2

**Duties and Responsibilities**:

- Provide superior customer service and demonstrate a professional and positive attitude toward internal and external contacts at all times.
- Communicate with Regulatory authorities and maintain product licenses of Rapid Aid.
- Manage, coach, develop, and maintain Quality System to meet regulations of the countries where products are sold.
- Ensure the efficient management of quality control data by inputting, maintaining, tracking and storing data, and producing reports.
- Ensure professional correspondence is maintained and provided in a timely manner with customers and internal departments.
- Provide recommendations for improving the level of quality and service from quality and regulatory perspectives.
- Assist President to organize the regular management review and internal quality projects.
- Maintain clear and open lines of communication between Quality Assurance and other internal departments.
- Keep management informed as to day-to-day quality issues and relevant information.
- Manage the recruitment and staffing of the Quality Assurance departments.
- Work closely with the Management Team in the implementation, communication and planning of the quality system.
- Ensure compliance with Health Canada and FDA Regulations and other Agencies as required.
- Oversee Quality Management System, maintain documentation, and train auditors.
- Manage, schedule and participate in the internal and external audits and inspections from regulatory authorities and customers.
- Ensure post-marketing regulatory procedures and activities meet regulatory requirements.

**Skills and Qualifications**:

- 5+ years proven work experience in Quality Assurance in a manufacturing, preferably ISO environment
- Bachelor degree in Engineering or science and MBA is a plus.
- Knowledge of FDA and Health Canada, CE Markings, ISO standards, Good Manufacturing Practices, and Therapeutic Products Program
- 2 - 3 years previous management experience
- ISO Lead Auditor training
- Strong leadership and coaching capabilities that focus on team building and staff development
- Excellent communication skills, both written and verbal are required
- Good analytical, diagnostic and problem-solving skills
- With strong time management skills, work with internal and external customers to solve problems in a timely manner in order to provide reliable, compliant systems
- The ability to work and cooperate with others to accomplish group, and corporate goals and objectives
- The ability to manage several projects at once while setting specific goals & timelines for completion
- Proficient computer and data tracking skills

**Job Types**: Full-time, Permanent

**Salary**: $55,000.00-$65,000.00 per year

**Benefits**:

- Casual dress
- Company events
- Dental care
- Extended health care
- On-site parking
- Vision care

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday

Supplemental pay types:

- Bonus pay

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- quality assurance: 4 years (preferred)

Work Location: One location