Role Summary

The Assistant Manager Technical is a leadership role responsible for driving technical excellence, quality system performance, certification readiness, and capability building across all QA/QC levels . This role leads to the implementation and maintenance of integrated quality systems, supports new projects and validations, drives customer and supplier quality initiatives, and ensures robust data-driven improvements. The Assistant Manager also plays a major role in departmental growth, team skills development, and operational discipline through daily reviews and KPI-driven actions.

Key Responsibilities

1) Leadership & People Development

- Lead and mentor QA/QC teams, ensuring consistent execution of quality practices.
- Drive skills development through training plans, coaching, competency mapping, and performance improvement actions.
- Conduct daily meetings with QA team members to review routine activities, issues, KPI performance, and value-add projects.

2) Certification & Management System Leadership (IMS / MDQMS)

- Lead and conduct certification activities including IMS (Integrated Management System) and MDQMS (Medical Device Quality Management System), ensuring system compliance and readiness.
- Coordinate certification audits, stage audits, surveillance audits, and re-certification activities with external bodies.
- Ensure timely closure of certification audit findings with solid CAPA, effectiveness checks, and evidence documentation.
- Maintain a certification compliance calendar and system health dashboards to ensure continuous readiness.

3) Audit Planning & Internal Audit Program

- Plan and publish internal audit schedules (annual/quarterly/monthly) for QMS/IMS/MDQMS requirements.
- Lead internal audit execution directly or through trained internal auditors; review audit reports and ensure closure of findings.
- Track audit actions and drive cross-functional improvements to prevent repeat non-conformances.
- Ensure audit preparedness across departments: Production, Warehouse, Dispatch, Maintenance, and Lab.

4) Quality Systems Governance & Documentation Control

- Strengthening Quality Management System including SOPs, WIs, formats, change control, deviations, NCRs, risk assessment, and CAPA.




- Ensure controlled documentation: revision control, approvals, obsolescence, training linkage, and availability at point of use.
- Support Technical Manager in annual quality planning and system improvements.

5) Customer Complaint Management & RCA/CAPA Oversight

- Guide and validate complex customer complaint investigations led by Level3 engineers.
- Ensure structured RCA (5Why, Fishbone, Pareto) and high-quality CAPA implementation with effectiveness checks.
- Prepare executive summaries and customer-ready reports for complaints and major incidents.

6) Department KPI Ownership & Reporting

- Consolidate and validate KPI reports from all levels (defect trends, holds/rejects, customer complaints, audit closure, supplier issues, dispatch anomalies, etc.).
- Lead monthly KPI reviews with the QA team; provide recommendations and risk alerts to Technical Manager.
- Drive KPI-based improvement projects to reduce variation and improve first-pass quality.

7) New Projects, Equipment Purchase & Technical Negotiation

- Actively participate in new projects, line upgrades, expansions, and technology improvements.
- Support evaluation and technical negotiation for equipment purchase (Lab instruments / Inspection systems / Process equipment).
- Ensure installation qualification, calibration readiness, and performance acceptance of new equipment.

8) Process & Product Validation

- Lead/coordinate process validation and product validation activities including IQ/OQ/PQ (as applicable).
- Ensure validation plans, protocols, reports, and traceable evidence are maintained and audit ready.
- Support qualification of new products/trials and ensure compliance to customer/internal specifications.

9) Lab Coordination, Method Validation & Measurement System Analysis

- Ensure lab compliance: calibration, maintenance schedules,



test method robustness, and audit readiness.
- Lead Gauge R&R; studies, measurement system capability, and method validation for critical tests.
- Improve lab reliability and inter-shift consistency in test results.

10) Specifications Development & Customer Approvals

- Lead the creation, review, and change management of product specifications and test methods.
- Coordinate internal approvals and ensure specifications are submitted and approved by customers where required.
- Ensure communication and deployment of updated specifications across production and QA teams.

11) Data Analysis, Trend Monitoring & Continuous Improvement

- Review trend analysis (product properties, vision system defect trends, raw material variability) and convert insights into corrective actions.
- Support process capability improvement initiatives and implement preventive controls.
- Lead value-add projects focused on waste reduction, defect reduction, and process stability improvements.

12) Supplier Quality & Development

- Participate in supplier audits and technical visits for raw materials (polymers, masterbatches, additives, chemicals, cores, films).
- Support supplier corrective action verification, supplier rating/scorecards, and risk mitigation actions.
- Align with procurement and management for supplier improvement plans.

13) Cross-Functional Coordination & Daily Governance

- Coordinate with Production, Engineering, Maintenance, Warehouse, and Dispatch teams to ensure smooth execution of quality requirements.
- Validate dispatch goods readiness and ensure anomalies are corrected before shipment.
- Ensure structured shift/department handovers for quality status and action tracking.

Core Skills

- IMS / QMS / MDQMS system implementation and certification handling.
- Internal audit planning and audit program management.
- RCA/CAPA, risk assessment, change control.
- Process and product validation; IQ/OQ/PQ exposure.
- Gauge R&R; / MSA, lab compliance and test method validation.
- Data analysis (Excel/Power BI preferred), KPI reporting.
- Customer and supplier interaction, audits, and negotiations.
- ERP and documentation discipline.

📌 Assistant Manager - Technical (Bengaluru)
🏢 Manjushree Spntek
📍 Bengaluru