Manager - Quality Control

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.