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Quality Assurance Manager
3 weeks ago
**Position**: Quality Assurance Manager
**Location**: Remote in Canada
The QA Manager is responsible for overseeing the quality assurance processes and procedures within the organization to ensure compliance with regulatory requirements, industry standards, and customer expectations. This role involves leading a team of quality professionals, implementing quality systems, conducting audits, and driving continuous improvement initiatives. The QA Manager collaborates with cross-functional teams to maintain and enhance product quality, customer satisfaction, and overall operational excellence.
**Responsibilities**:
- **Develop and implement quality systems**: Establish and maintain robust quality management systems (QMS) compliant with applicable regulations and standards (e.g., ISO 9001, FDA regulations). Define and document quality policies, procedures, and work instructions to guide the organization in achieving quality objectives.
- **Team leadership**: Lead and manage a team of quality professionals, providing guidance, coaching, and performance management. Foster a culture of quality, collaboration, and continuous improvement within the QA team.
- **Compliance and regulatory affairs**: Ensure compliance with relevant regulatory requirements and industry standards. Stay updated on changes to regulations and communicate the impact to the organization. Collaborate with regulatory affairs teams to support regulatory submissions and audits.
- **Quality audits and inspections**: Plan and conduct internal quality audits to assess compliance with quality systems, identify gaps, and drive corrective and preventive actions (CAPA). Prepare the organization for external audits and inspections by regulatory authorities or certification bodies.
- **Supplier quality management**: Collaborate with purchasing and supplier management teams to establish and maintain a robust supplier quality management program. Evaluate and select suppliers based on their ability to meet quality requirements. Conduct supplier audits and ensure timely resolution of supplier-related quality issues.
- **Complaint handling and product investigations**: Oversee the complaint handling process and ensure timely and effective resolution of customer complaints. Lead investigations into product non-conformities, root cause analysis, and implementation of corrective and preventive actions (CAPA).
- **Continuous improvement**: Drive continuous improvement initiatives to enhance quality systems, processes, and product quality. Utilize tools and methodologies such as Lean Six Sigma to identify and implement process efficiencies and reduce waste.
- **Training and development**: Provide training and guidance on quality systems, processes, and regulatory requirements to employees at all levels of the organization. Promote a culture of quality awareness and empower employees to take ownership of quality.
- **Metrics and reporting**: Define and track key quality metrics to monitor performance, identify trends, and drive improvement initiatives. Prepare regular reports on quality performance for management review and decision-making.
**Requirements**:
- Bachelor's degree in a relevant scientific or engineering field is required. Advanced degree (Master's or Ph.D.) is preferred.
- Proven experience (typically 5+ years) in quality assurance roles, preferably in a regulated industry such as pharmaceuticals, medical devices, or manufacturing.
- In-depth knowledge of quality management systems (QMS) and relevant regulations and standards (e.g., ISO 9001, FDA regulations).
- Strong understanding of quality principles, methodologies, and tools, such as Lean Six Sigma.
- Experience in leading and managing a team, with strong leadership and people management skills.
- Familiarity with regulatory requirements and standards specific to the industry of the organization.
- Excellent analytical and problem-solving skills, with attention to detail and the ability to make data-driven decisions.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and communicate complex quality concepts to various stakeholders.
- Knowledge of auditing principles and experience in conducting internal and external audits.
- Continuous improvement mindset and the ability to drive change and implement process improvements.
- Strong organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
- Certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Six Sigma Green/Black Belt are desirable.
