Manager - Quality (Devices)

Job Description

QC Manager: Title: Quality Control Manager Location: Bangalore, India Organization: Inito (Samplytics Technologies Pvt Ltd) Work Experience: 8 to 12 years Job Description We are seeking a passionate and results-driven Quality Control Manager to lead and inspire a high-performing team in ensuring exceptional product quality and compliance. In this role, you will oversee critical quality control initiatives, including method validation, process optimization, and quality assurance activities, ensuring the delivery of reliable and high-performing products. You will play a pivotal role in maintaining regulatory compliance, driving innovation in QC processes, and fostering a culture of excellence. As a mentor and leader, you will empower your team to excel and contribute to Initos mission of delivering transformative, world-class diagnostic solutions. Final JD: Key Responsibilities : Quality Assurance & Control : Develop and implement robust QA/QC processes to ensure compliance with ISO 13485, FDA CFR 21, industry regulations, and internal standards. Monitor compliance through regular audits, inspections, and investigations (CAPA, OOS, OOT, Deviation, and Incidence). Manage QC systems to address deficiencies and ensure timely corrective and preventive actions. Analytical Excellence : Oversee analytical method development, validation, and verification for Assay, impurities, and residual solvents. Review and approve protocols, test reports, and stability testing records to ensure accuracy and completeness. Documentation & Compliance : Prepare, review, and maintain essential documents, including SOPs, specifications, test protocols, and APQRs. Ensure timely and accurate documentation for regulatory submissions and customer compliance. Collaborate with QA to prepare for audits and regulatory inspections, ensuring adherence to global standards. Team Leadership & Collaboration : Lead and mentor a team of quality professionals, fostering a culture of excellence and accountability. Train staff on QA/QC procedures, regulatory updates, and best practices. Collaborate with cross-functional teams to resolve quality-related issues and implement process improvements. Strategic Oversight : Drive sustainability and innovation in quality management, ensuring timely release of materials and finished products. Stay updated with industry trends and regulatory changes, proactively aligning processes to maintain compliance. Product Development: Should have exp in prod testing and prod dev ISO13485/medical Experience is a plus. Develop testing and quality for new product and work with the design team to set up quality strategy KPI: Build QC Framework for all Existing Products (6 Months) Get Visibility from Centum Get visibility from Optics Internal Assembly Get Visibility from NG Vendor Translate all QC to Vendors and Not do In-House (6 Months) Plastics PCB-A Optics Responsible for Implementing Data Pipeline at all Vendors (6 Months) Also responsible for New Vendor audits for QC capability Responsible for maintaining QC adherence and Data availability at all Vendors Run Audits with all Vendors every 6 months Ensure New Projects are implemented with good standards Run ORT and Ensure Product is Compliant Vendor process is Compliant Responsible for Commissioning and Maintenance of QC Systems and Machines at all Vendor Locations Hire and Build a Self Sufficient Team