JOB DESCRIPTIONManager – Incoming Quality Control (IQC)

Product: Blood Glucose Meters & Analyzers

Industry: IVD / Medical Devices / Electronics Manufacturing

Location: IMT Manesar, Haryana

Department: Quality / IQC

Reporting To: Head – Quality / Quality Director

- Job Purpose To lead and manage the Incoming Quality Control (IQC) function for Blood Glucose Meters, Analyzers and related electronic/mechanical components, ensuring that all incoming materials meet defined quality, technical, regulatory and QMS requirements before release to production.

The role will be responsible for establishing robust incoming inspection systems, supplier quality controls, material acceptance standards, defect prevention, traceability, and continuous improvement in line with ISO 13485, GMP and applicable IVD/medical-device requirements.

Candidates from electronic product manufacturing such as medical electronics, consumer electronics, automotive electronics, industrial electronics, instrumentation or similar industries may be considered, provided they have strong practical knowledge of Quality Management Systems and incoming quality controls.

- Key ResponsibilitiesA. IQC Operations & Incoming Inspection

- Lead day-to-day IQC activities for electronic, mechanical, plastic, packaging and other incoming materials.
- Define and maintain incoming inspection plans, sampling plans, specifications and acceptance criteria.
- Ensure inspection of critical components such as:
- PCB/PCBA
- ICs and electronic components
- Sensors
- Displays
- Connectors
- Batteries
- Cables and wires
- Plastic/injection-moulded parts
- Mechanical components
- Packaging materials
- Consumables and accessories.
- Ensure proper identification, segregation and disposition of Accepted / Rejected / Hold materials.
- Monitor IQC rejection, defect trends and material-related production issues.
- Ensure timely closure of inspection reports and material release.

B. QMS & Medical Device Quality
- Ensure IQC processes comply with ISO 13485 and company QMS requirements.
- Maintain effective control of quality records, inspection reports, specifications, standards and traceability documents.
- Support internal, external, customer and regulatory audits related to IQC.
- Ensure implementation and effectiveness of:
- Non-Conformance Control
- CAPA
- Change Control
- Deviation Management
- Risk-based controls
- Document Control
- Training & Competency
- Traceability requirements.
- Participate in FMEA / Risk Management activities related to incoming materials and components.
- Ensure inspection methods and acceptance criteria are aligned with approved specifications and product requirements.

C. Supplier Quality Management
- Work closely with Supplier Quality / Purchase / R&D; / Production / QA for supplier quality improvement.
- Monitor supplier incoming quality performance and prepare Supplier Quality Scorecards.
- Lead supplier-related rejection, complaint and recurring defect investigations.
- Ensure suppliers submit effective Root Cause Analysis and CAPA for quality issues.
- Support supplier audits and supplier qualification activities where required.
- Drive reduction of supplier PPM, rejection rate and recurring defects.

D.



Electronic & Product Quality Knowledge The candidate should have practical understanding of electronic manufacturing and quality controls, including:
- PCB/PCBA manufacturing and inspection
- SMT/THT processes
- Electronic component specifications
- Soldering and workmanship standards
- ESD controls
- Electrical/electronic testing
- Functional testing
- Basic knowledge of sensors and measurement systems
- Battery and power-related components
- Display/interface components
- Calibration and measuring equipment
- Basic understanding of software-controlled/electronic medical devices.

Knowledge of blood glucose meter/analyzer components, sensors, strips, measurement principles or IVD products will be an added advantage.

E. Non-Conformance & CAPA

- Lead investigation of incoming material non-conformities.
- Perform/guide 5 Why, Fishbone, 8D and other RCA methodologies.
- Ensure proper containment, correction, corrective action and preventive action.
- Monitor CAPA effectiveness and prevent recurrence.
- Analyze recurring defects and initiate systemic improvement.

F. Quality Data & Continuous Improvement
- Develop and monitor IQC KPIs and dashboards, including:
- Incoming Rejection Rate
- Supplier PPM
- Lot Rejection Rate
- Critical/Major/Minor Defects
- Supplier CAPA Closure
- Inspection Cycle Time
- Repeat Defect Rate
- Cost of Poor Quality.
- Conduct monthly quality trend analysis and management review inputs.
- Drive continuous improvement through Pareto analysis, defect trend analysis and process improvement projects.
- Reduce inspection-related delays without compromising product quality or QMS compliance.

G. Cross-Functional Coordination

Work closely with

- QA
- QC
- Production
- R&D; / Product Development
- Engineering
- Purchase
- Supply Chain
- Warehouse
- Supplier Quality
- Regulatory Affairs

to ensure timely resolution of material and component quality issues.
- Required Qualification

Essential:

- B.E./B.Tech in Electronics, Electrical, Instrumentation, Mechanical, Production or related engineering discipline.
- 10–20 years of relevant experience in IQC / Incoming Quality / Supplier Quality / Electronics Manufacturing Quality.
- Strong practical knowledge of QMS and quality control systems.

Preferred:

- Experience in IVD / medical devices / healthcare electronics.
- Experience with Blood Glucose Meter, Analyzer, POCT or diagnostic equipment.
- Knowledge of ISO 13485 / GMP / medical-device QMS.

4. Required Technical & QMS Knowledge The candidate should have working knowledge of:
- ISO 13485
- GMP
- QMS documentation and procedures
- Incoming Inspection
- Sampling Plans / AQL
- Control Plans
- Specification & Drawing Control
- Non-Conformance Management
- CAPA
- 8D / 5 Why / Fishbone
- FMEA / Risk Management
- Change Control
- Supplier Quality Management
- Calibration & Measuring Equipment Control
- Traceability
- ESD controls
- PCB/PCBA quality
- Electronic component inspection




- Statistical Quality Control
- Pareto / Trend Analysis
- Root Cause Analysis
- Audit preparation and compliance.

5. Leadership Responsibilities
- Lead and develop the IQC team through structured training and competency assessment.
- Establish clear responsibilities, inspection standards and escalation mechanisms.
- Ensure disciplined execution of IQC procedures and QMS requirements.
- Review team performance and quality KPIs.
- Build a proactive quality culture focused on defect prevention rather than defect detection.
- Develop standardized inspection practices across different products/material categories.

6. Key Competencies
- Strong analytical and problem-solving ability
- Strong knowledge of QMS and documentation
- Good understanding of electronics manufacturing
- Supplier quality management
- Root Cause Analysis
- Data-driven decision making
- Audit readiness
- Cross-functional coordination
- Team leadership
- Valuable communication and reporting skills
- Ability to work in a regulated medical-device/IVD environment
- Strong attention to detail and traceability.

7. Preferred Industry Background

Candidates may be considered from:

Preferred

- IVD / Medical Devices
- Diagnostic Equipment
- Medical Electronics
- Healthcare Electronics

Also acceptable

- Electronics Manufacturing
- Consumer Electronics
- Automotive Electronics
- Industrial Electronics
- Instrumentation
- Electrical/Electronic Product Manufacturing

Important: Candidates from electronics manufacturing should demonstrate strong practical knowledge of QMS, incoming inspection, supplier quality, CAPA, non-conformance management and audit requirements.

- Key Performance Indicators (KPIs)

- IQC rejection rate / PPM
- Supplier PPM
- Incoming lot acceptance rate
- Critical defect occurrence
- Repeat defect rate
- Supplier CAPA closure on time
- IQC inspection turnaround time
- Material-related production stoppage
- Cost of Poor Quality
- Audit NC/Observation related to IQC
- Effectiveness of corrective actions
- Supplier quality improvement.

Key KPIs
- Production Plan Achievement
- Production Schedule Adherence
- On-Time Production Completion
- Material Availability
- Capacity Utilization
- Inventory Turnover
- WIP Level
- Production Lead Time
- Material Shortage Incidents
- Production Order Closure
- Planning MIS Accuracy

Behavioral Competencies
- Leadership & Team Management
- Analytical Thinking
- Decision Making
- Planning & Organizing
- Problem Solving
- Communication
- Cross-Functional Coordination
- Accountability
- Continuous Improvement Mindset

Salary: As per company standards and candidate experience.

Employment Type

Full-Time | Permanent

Why Join SD Biosensor Healthcare Pvt. Ltd.?

- Work with a global leader in In-Vitro Diagnostics (IVD).
- Opportunity to lead advanced FIA manufacturing operations.
- Exposure to international quality and regulatory standards.
- Career growth in a rapidly expanding medical device organization.
- Collaborative and innovation-driven work environment.

Pay: ₹70,000.00 - ₹180,000.00 per month

Benefits

- Cell phone reimbursement
- Food provided
- Health insurance
- Leave encashment
- Life insurance
- Provident Fund

Work Location: In person

📌 Manager Quality Control (Gurugram)
🏢 SD Biosensor Healthcare
📍 Gurugram