About the Role:

The Quality Assurance Manager will lead and oversee the development, implementation, and maintenance of quality management systems to ensure products and services meet or exceed regulatory and customer requirements. This role is critical in driving continuous improvement initiatives and managing corrective and preventive actions to enhance overall quality performance. The manager will collaborate cross-functionally with suppliers, production, and regulatory teams to uphold compliance with ISO 13485 standards and other relevant quality frameworks. They will be responsible for establishing robust quality programs that mitigate risks and ensure consistent product reliability and safety. Ultimately, this position ensures that the organization maintains a culture of quality excellence, supporting business objectives and customer satisfaction.

Minimum Qualifications:

• Bachelor's degree in Engineering, Quality Management, or a related field.
• Minimum of 5 years of experience in quality assurance within a regulated industry, preferably medical devices or manufacturing.
• Proven expertise in quality systems, corrective and preventive actions, and supplier quality management.
• Strong knowledge of ISO 13485 standards and regulatory requirements.
• Demonstrated ability to lead quality audits and manage corrective action plans effectively.

Preferred Qualifications:

• Certified Quality Auditor (CQA) or Certified Manager of Quality/Organizational Excellence (CMQ/OE) certification.
• Experience with advanced quality tools such as Six Sigma, Lean, or Failure Mode and Effects Analysis (FMEA).
• Familiarity with electronic quality management systems (eQMS) and quality data analytics.
• Previous leadership experience managing a quality assurance team.
• Knowledge of FDA regulations and international quality standards beyond ISO 13485.

Responsibilities:

• Develop, implement, and maintain quality management systems in compliance with ISO 13485 and other applicable standards.
• Lead investigations and root cause analysis for quality issues, managing corrective and preventive action plans to resolution.
• Coordinate supplier quality management activities, including audits, performance monitoring, and improvement initiatives.
• Collaborate with cross-functional teams to integrate quality processes into product development and manufacturing workflows.
• Monitor quality metrics and prepare reports to communicate quality performance and improvement opportunities to senior leadership.

Skills:

The required skills such as quality systems and corrective action are applied daily to ensure compliance and continuous improvement within the organization's quality framework. The Quality Assurance Manager uses expertise in quality processes and programs to design and implement effective quality controls and risk mitigation strategies. Supplier quality management skills are essential for evaluating and improving supplier performance, ensuring that external components meet stringent quality standards. Knowledge of ISO 13485 guides the development and maintenance of compliant quality management systems, critical for regulatory adherence. Additionally, skills in corrective and preventive actions enable the manager to systematically address quality issues, preventing recurrence and fostering a culture of proactive quality management.