Quality Assurance Manager
2 weeks ago
**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
- The ability to travel to China Quarterly
**Salary**: $70,000.00 per year
**Benefits**:
- Dental care
- Life insurance
- Paid time off
- Vision care
Schedule:
- Monday to Friday
Supplemental pay types:
- Bonus pay
Ability to commute/relocate:
- Mississauga, ON L5L 5X3: reliably commute or plan to relocate before starting work (required)
**Education**:
- Bachelor's Degree (preferred)
**Experience**:
- quality assurance: 1 year (required)
Work Location: In person
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