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 Mentorship
· Strategic Thinking & Decision Making
· Cross-Functional Collaboration
· Attention to Detail
· Proactive in Driving Continuous Improvement
· Adaptability in a Regulated Environment
Key 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 members
· Represent the quality function at management reviews and strategic meetings
· Final 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 implication
· Contribute to the development and implementation of product test plans including Verification and Validation of products and processes
· External QC/COC
· Involve in the maintenance of product documentations (DHF)
· Participate in supplier audits along with Supply Chain
· Preparation 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.
