Makers Hive Innovations Pvt. Ltd. General Job Purpose We are looking for a reliable Manager of Quality Assurance & Regulatory Affairs to ensure that all external and internal requirements are met before our product reaches our customers. You will be responsible for inspecting procedures, and outputs, processes, regularity compliance requirements, and identifying mistakes or non-conformity issues. The goal is to assure the high quality of our operations and services aiming to the long-term success of our business. 1. Job
Responsibilities:
• Maintaining QMS and being responsible for the overall quality of the process and oversee the management and compliance with the procedures, data models, policies, and technologies associated with the process.
• Conducting regular Compliance Audits and risk assessment for all Products/Projects.
• Responsible for planning, Scheduling, Execution and Reporting the audits performed.
• Identifying root cause and CAPA for the raised non-conformances along with the engineering team support and help team to implement Change Control Forms.
• Supporting Product Development teams (Development, testing) for each release in documentation and Release management.
• Creating project plans, continuous monitoring of project teams prior to end of each milestone to limit the process & Project deviations.
• Work closely with the production manager and management to create SOPs, organize training sessions.
• Develop Roles, tasks, activities, Process, sub process, scenarios and manage issues of a team or product.
• Providing support to Project teams in following the process and process documents, defined in Quality Management System.
• Maintaining all process documents with version control.
• Reporting the status of projects to senior management, periodically.
• Working on improving the QMS and inducting best practices into the Organization.
• Reviewing plans, procedures and standards to adhere organizational goals and practices.
• Proposing corrective actions to overcome the deviations in the actual project plans.
• Revise procedures to inspect and report quality issues and monitor all operations that affect quality.
• Facilitate proactive solutions by collecting and analysing quality data.
• Review current standards and policies.
• Ensure all legal standards are met. 2.
Education/Experience/Skills: 1. Bachelor of Technology or B.
Sc / BA in business administration or relevant field 2. At least 5+ years of experience in Quality systems and project management 3. Must have hands-on experience in implementation of quality standards like ISO 13485 4. Must have knowledge of regulations such as GDPR, HIPAA and standards such as ISO 27001 5. Good knowledge on agile project management 6. Prior Auditor experience for ISO 9001:2015 or ISO 13485 7. Knowledge/real time experience in getting CE Mark Approval for a Medical Device. 8. Knowledge/real time experience in getting Manufacturing License from CDSCO. 9. Knowledge of medical devices industry is a plus 10. Proven experience as a quality assurance manager or relevant role 11. Thorough knowledge of methodologies of quality assurance and standards 12. Valuable knowledge of MS Office and Excel 13. Outstanding communication skills 14. Great attention to detail and a result driven approach 15. Excellent organizational and leadership abilities 16. Reliable and Trustworthy 17. Spoken English, Telugu and Hindi is a must