Quality Assurance Manager

1 week ago

Chandigarh, Chandigarh, India Domnic Lewis International Full time
Job Description

Overview:

We are seeking a highly skilled Quality Assurance Manager to lead our quality management initiatives in South Asia. The successful candidate will be responsible for ensuring compliance with ISO 9001 and ISO 13485 standards, as well as other relevant regulations.

Responsibilities:

  • Design and Implementation of QMS: Develop and implement quality management policies and procedures to meet industry standards.
  • System Integration and Monitoring: Integrate global management system SOPs into local systems and ensure compliance with regional and global standards.
  • Sales and Service Contracts: Ensure quality management system incorporates requirements from Sales and Service contracts.
  • Training and Staff Awareness: Train staff members on their roles within the quality management system and maintain training records.
  • Non-conformance Management: Manage non-conformances within the organization and take corrective actions where necessary.
  • Reporting: Compile and present monthly QRC reports to senior management.
  • Key Performance Indicators (KPIs) and Metrics: Identify, monitor, and report on quality metrics.
  • Document and Data Control: Maintain document control systems to ensure proper documentation and data management.
  • Supplier and Distributor Audits: Conduct quality audits for suppliers and distributors as needed.

Complaints Handling Responsibilities:

  • Complaint and Incident Management: Report warranties, unplanned service incidents, product issues, business complaints, non-conformances, and CAPA in accordance with local or global SOPs.
  • KPI Monitoring: Monitor complaints handling KPIs.

General Responsibilities:

  • Regulatory Affairs Support: Provide backup support to Regulatory Affairs team in areas related to regulatory compliance and post-market activities.
  • Compliance Issue Identification: Discuss emerging or potential compliance issues with management and employees.
  • Industry Trends and Best Practices: Stay informed about changes in the industry, trends, and best practices.
  • Process Improvement: Design and implement improvements in communication, monitoring, and enforcement of compliance standards.
  • Project Monitoring: Oversee projects to ensure objectives, success criteria, quality, and time frames are achieved.
  • Customer Relationship Management: Maintain strong relationships with existing customers by ensuring compliance with contract requirements and providing quality service.

Requirements:

  • In-depth Knowledge of Standards: Extensive knowledge of ISO 9001 and ISO 13485 as they pertain to the Medical Device Industry.
  • Auditor Qualifications: Certification in ISO 13485 auditing.
  • Risk Management Expertise: Ability to apply current risk management standards, principles, and frameworks.
  • Communication Skills: Strong verbal and written communication skills.
  • Self-management: Ability to work with minimal supervision, meet agreed-upon deadlines, and prioritize tasks effectively.
  • Technical Proficiency: Proficiency in Microsoft Office Suite and other relevant tools.
  • Cross-functional Teamwork: Ability to collaborate effectively with local, regional, and global teams.
  • Training Experience: Experience in developing and delivering training programs.
  • Complaint Handling Expertise: Experience with complaint handling processes and practices.
  • Legislation Knowledge: Familiarity with relevant legislation and ability to acquire knowledge of pertinent codes and practices.
  • Regulatory Affairs Expertise: Knowledge of regulatory affairs within South Asia and the Middle East.

Estimated Salary: ₹15,00,000 - ₹25,00,000 per annum based on location and experience.

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