Job Description

POSITION PURPOSE The purpose of this position is to develop, implement and monitor quality strategies. This position ensures compliance with established standards and agency guidelines such as MDSAP, ISO13485:2016, and Health Canada by providing direction to the site team members to maintain and improve quality (and regulatory) compliance. SUMMARY OF RESPONSIBILITIES Develop and implement QA strategies. Act as a Management Representative and implement quality system procedures and initiatives in order to achieve compliance with requirements. Coordinate and lead internal and external audits, maintain quality assurance programs, policies, processes, procedures, and controls ensuring that the performance and quality of the products conform to established standards and agency guidelines. Provide leadership for quality system improvements, and business process improvement initiatives. Responsible for the creation, preparation, and achievement of regulatory submissions and approvals to introduce new products in Canada. KEY RESPONSIBILITIES ? Scheduling, planning, and hosting client audit and regulatory inspections (for DEL, MDEL, etc.). ? Lead and/or provide support for license renewals to the Regulatory team when required. ? Evaluate client audit and regulatory inspection findings and prepare and distribute reports to operations staff, management, and customers. ? Prepare written responses for the regulatory inspections along with the CAPA plans. This should be developed using quality risk management principles. ? Investigate the regulatory findings, determine the root causes, and provide the proposed CAPAs ? Co-ordinate shipments of finished goods ? Receive, Inspect, and sample finished goods for testing ? Prepare/Review product release documents/records (inspection reports, investigation and CAPA reports, and other product disposition-related records) for the Canadian market ? Transmit samples for testing to the contract laboratory ? Review test results and ensure they meet specifications ? Evaluation of the OOS related to product testing and ensure that the products meet the specifications prior to release ? Review the completion of warehouse logs (temperature/humidity, cleaning, calibration, etc.) ? Review of the site receiving logs and finished goods inventory ? Management of returned products ? Archiving of retained samples for finished goods ? Review and approval of SOPs and stability programs ? Offer suggestions for process improvement when identified ? Organizes and maintains paper-based and electronic filing systems ? Creates and maintains database and spreadsheet files ? Lead (prepare, arrange, and execute) self-inspection/internal audits for compliance with ISO 13485, GMP, and International Regulations related to medical devices, natural health products, and pharmaceutical products ? Lead Deviation investigations, CAPAs, Change control, and other quality management system elements ? Perform self-inspection/internal and external audits of NeilMed facilities and outside suppliers and vendors as required ? Review and approve procedures, forms, protocols, reports, and specifications products for the Canadian market. ? Lead or assist Management Review per current Quality Systems requirements ? Support stability studies for products by reviewing and approval of stability protocols and reports ? Support Regulatory submissions and ongoing regulatory compliance for the product development process if needed ? Review product labeling for compliance with the Canadian regulations ? Provide technical guidance and training/mentoring to the cross-functional teams ? Develop and implement departmental and divisional policies and procedures ? Review of the evidence of GMP compliance of foreign suppliers ? Review and assessment of all product complaints ? Other duties as assigned QUALIFICATION REQUIREMENTS (EXPERIENCE, TRAINING, SKILLS, EDUCATION) KNOWLEDGE/EDUCATION ? Bachelor or Master in science (Preferred Biology or Chemistry or related fields) ? Certified Quality Auditor by ASQ (Preferred) ? Knowledge of Health Canada (and FDA) regulations, guidance, and import/exports requirements for Medical Devices, Natural Health Products, and Pharmaceuticals ? Knowledge of product labeling and promotional requirements ? Strong understanding of the quality system requirements ? Thorough knowledge of product development process, design control, and Quality Systems ? Strong technical knowledge of medical device products EXPERIENCE ? Minimum 5 years of Quality experience as a manager or higher-level position ? Demonstrated success in Quality management ? Knowledge or experience in Risk management, CAPA management, change control systems, and Quality improvements ? Statistical analysis and problem-solving ability strongly preferred Job Type: Full-time Pay: $59,032.97-$119,777.09 per year Benefits:

• Dental care
• Employee assistance program
• Life insurance
• Paid time off
• Relocation assistance
• Vision care

Flexible Language Requirement:

• French not required

Schedule:

• 8 hour shift
• Monday to Friday
• Morning shift

Ability to commute/relocate:

• Markham, ON L3R 8C3: reliably commute or plan to relocate before starting work (required)

Education:

• Bachelor's Degree (required)

Experience:

• quality assurance: 5 years (preferred)

Work Location: In person