Assistant Quality Manager / Quality Section Manager (Healthcare)

JOB SUMMARY

Assist Quality Manager to manage the Quality Engineering and Quality Assurance functions to ensure compliance with applicable regulatory requirements, Quality Management System (QMS) standards, customer requirements, and company objectives.

Provide strategic and technical leadership to support manufacturing operations, New Product Introduction (NPI), supplier quality, customer quality, and continuous improvement initiatives for healthcare and non healthcare finished medical device.

Collaborate closely with cross-functional teams and healthcare customers to drive product quality, operational excellence, and regulatory compliance within a medical device manufacturing environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Leadership & People Management

• Assist Quality Manager on coach, mentor and develop Quality Engineers, Quality Technicians, and Inspectors to achieve quality and business objectives.
• Drive departmental goals, KPIs and performance expectations aligned with site quality strategy.
• Identify training needs and ensure compliance with quality and regulatory training requirements.
• Foster a culture of behavior based quality, accountability, continuous improvement and customer focus.
• Lead the quality organization during customer escalations, quality crises, product containment and recovery activities.
• Promote collaboration across Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and Operations teams.

Quality Management System (QMS)

• Ensure effective implementation, maintenance and continuous improvement of the Quality Management System in compliance with:
  • ISO 13485
  • FDA 21 CFR Part 820 / QMSR
  • MDSAP
  • Customer-specific requirements
• Monitor QMS metrics and drive system improvements.
• Review and approve quality procedures, work instructions, specifications, forms and records.
• Support Management Review and Quality Review Board activities.

Quality & Technical Management

• Lead Quality Engineering support for manufacturing operations and NPI projects.
• Develop and maintain Quality Plans, Control Plans and APQP deliverables.
• Drive process validation and qualification activities including IQ, OQ and PQ.
• Lead Process FMEA, Risk Assessment and Control Plan development.
• Support quotation and transfer activities through quality planning and risk evaluation.
• Establish inspection methodologies, acceptance criteria, sampling plans and measurement systems.
• Review and improve inspection processes, gauges, fixtures and quality controls.
• Analyze quality performance data and identify opportunities for process improvement.
• Lead implementation of SPC, process capability studies and quality monitoring systems.
• Partner with Engineering and Operations to improve yield, reduce defects and lower Cost of Poor Quality (COPQ).

CAPA, Nonconformance & Complaint Management

• Lead investigations related to:
  • Nonconforming product
  • Customer complaints
  • Audit findings
  • Process deviations
  • Supplier quality issues
• Utilize structured problem-solving methodologies including:
  • 8D
  • 5 Why
  • Fishbone Analysis
• Ensure timely implementation and closure of corrective and preventive actions (CAPA).
• Verify effectiveness of CAPA actions and drive sustainable solutions.
• Monitor recurring quality trends and drive systemic improvements.

Customer Quality Management

• Serve as quality interface for healthcare and medical device customers.
• Lead responses to customer quality issues, complaints, audits and corrective action requests.
• Facilitate customer visits, quality reviews and business review meetings.
• Support customer qualification, product transfers and new product launches.
• Drive customer satisfaction through proactive quality management and continuous improvement activities.

Supplier Quality Management

• Support supplier qualification, monitoring and development activities.
• Review supplier quality performance metrics and drive improvement actions.
• Lead Supplier Corrective Action Requests (SCAR) and supplier investigations.
• Participate in supplier audits and supplier process improvement initiatives.
• Partner with Supply Chain and Procurement teams to ensure supplier compliance.

Validation & Risk Management

• Ensure compliance with validation requirements for:
  • Equipment Qualification (IQ/OQ/PQ)
  • Process Validation
  • Software Validation
  • Packaging Validation
  • Test Method Validation
• Lead risk management activities in accordance with ISO 14971.
• Participate in Design Reviews, Process Reviews and Change Control evaluations.
• Assess quality and regulatory risks associated with product and process changes.

Audit & Regulatory Compliance

• Lead and support:
  • Internal Audits
  • Customer Audits
  • Supplier Audits
  • Regulatory Inspections
  • Certification Audits
• Ensure audit findings are addressed and closed within required timelines.
• Maintain a state of inspection readiness.
• Support implementation of regulatory and customer requirement changes.
• Ensure compliance with company policies, quality requirements, regulatory standards and industry best practices.

Business Strategy & Continuous Improvement

• Execute departmental quality strategies aligned with business goals.
• Drive Lean Manufacturing, Six Sigma and Operational Excellence initiatives.
• Establish quality improvement roadmaps to improve:
  • Customer satisfaction
  • Product quality
  • Operational efficiency
  • Regulatory compliance
• Monitor departmental performance and communicate results to management.
• Support annual operating plan and cost reduction initiatives.

PREFERRED REQUIREMENTS

Education

• Bachelor's Degree in Engineering, Biomedical Engineering, Manufacturing Engineering, Quality Management or related discipline.

Experience

• Minimum 7-10 years of Quality Engineering or Quality Assurance experience in medical devices, healthcare, life science or regulated manufacturing environments preferred,

• Experience in Surface Mount Technology (SMT), Printed Circuit Board Assembly (PCBA), and High-Level Assembly (HLA) manufacturing environments is preferred.
• Candidates should have practical exposure to process controls, inspection and testing requirements, defect analysis, corrective actions, and quality performance monitoring across these assembly operations.
• Experience supporting medical device, healthcare, or other regulated customers—including customer audits, product transfers, qualification activities, complaint investigations, and compliance with applicable quality and regulatory requirements—would be an added advantage.

• Minimum 3-5 years of leadership or supervisory experience.

Preferred Qualifications

• Lead / Auditor Certification (ISO 13485)
• ASQ Certified Quality Engineer (CQE) / Certified Quality Auditor (CQA) – optional

Key Knowledge & Skills

• ISO 13485
• FDA QSR / QMSR
• MDSAP
• ISO 14971 Risk Management
• APQP, PFMEA, Control Plan
• CAPA and Root Cause Analysis
• SPC and Statistical Analysis
• Process Validation (IQ/OQ/PQ)
• Supplier Quality Management
• Customer Quality Management
• Lean Manufacturing and Six Sigma
• Strong leadership and stakeholder management skills

Key Performance Indicators (KPIs)

• Customer Complaint Rate
• CAPA On-Time Closure %
• Audit Finding Closure Effectiveness
• First Pass Yield (FPY)
• Cost of Poor Quality (COPQ)
• Supplier PPM
• Internal Defect Rate
• Customer Escapes
• Regulatory Compliance Status
• Employee Development & Engagement

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