Assistant Quality Manager / Quality Section Manager

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

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

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.

• 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