About the Role -
Lead and manage the Quality team to ensure product and process compliance. Oversee inspections, audits, CAPA, and supplier quality. Support regulatory requirements and drive continuous improvement.
Technical Competencies -
- Quality Management Systems (QMS)
- Verification & Validation (V&V) of Products / Processes
- Final Quality Check (FQC) and Incoming Quality Control (IQC)
- Supplier Quality Management & Audits
- Regulatory Compliance
- Document Control (DHF, SOPs, Reports)
- NCMR (Non-Conformance Material Report) Management
- Product Complaint Handling & Data Analysis
- External Audits and Certifications
- Quality Metrics & KPI Monitoring
Behavioral Competencies -
Leadership & Team MentorshipStrategic Thinking & Decision MakingCross-Functional CollaborationAttention to DetailProactive in Driving Continuous ImprovementAdaptability in a Regulated EnvironmentKey Responsibility -
Lead, train and mentor quality team members.Overseeing incoming, and final inspection activities.Assigning the Daily Incoming Quality Control and Final Quality Check tasks and managing them.Establish and track KPIs for Quality Team membersRepresent the quality function at management reviews and strategic meetingsFinal Inspection of all products including service device along with complete documentation.Manage CAPA investigations, root cause analysis, and effectiveness checks.Monitor supplier quality performance and initiate supplier corrective actions as needed.Support external audits (FDA, Notified Body, customer)Ensure timely investigation and resolution of product complaints.Reviewing and analyzing complaint data, root-cause- investigations to establish corrective action plans and implicationContribute to the development and implementation of product test plans including Verification and Validation of products and processesExternal QC / COCInvolve in the maintenance of product documentations (DHF)Participate in supplier audits along with Supply ChainPreparation of monthly plan for FQC to achieve the target along with Operations Team.Managing the NCMR and coordinating with Supply Chain and suppliers to avoid rejections.Review of Assembly SOP, Final Quality Inspection Report, Device Verification and Validation Plan & Report and document it.Identify areas for improvement in processes, products, and systems.Promote a culture of continuous improvement using methodologies like Six Sigma, Lean, or Kaizen.Skills Required
Regulatory Compliance, Data Analysis