Imt Manesar Gurugram Haryana Maintenance manager Jobs – 616 Open Jobs Today

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13d

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Assistant Manager Quality

SD Biosenser Healthcare Pvt. Ltd.
IMT Manesar, Gurugram, Haryana

Quick apply

Job details

Full-time
₹6,04,055.36 - ₹13,25,355.94 a year

Benefits

Provident Fund
Commuter assistance
Leave encashment
Health insurance
Cell phone reimbursement
Food provided
Paid sick time

Qualifications

SAP
ERP systems
Regulatory reporting
Biotechnology
Microbiology
Master's degree
Analysis skills
Quality assurance
Bachelor's degree
Team management
Quality control
QA/QC
FMEA
Manufacturing
Communication skills

Full job description

VACANCY ANNOUNCEMENT

Job Description – Asst. or Dy Quality Manager

Company: SD Biosensor India Pvt. Ltd.
Location: IMT Manesar, Gurugram
Department: Quality Assurance / Quality Control
Designation: Manager – Quality
Reporting To: Head – Quality / Factory Head

1. Job Purpose

To lead and manage the Quality Assurance (QA), Quality Control (QC), Incoming Quality Control (IQC), Risk Management, Design & Development Quality, and Post Market Surveillance (PMS) activities in compliance with ISO 13485, CDSCO Medical Device Rules, and applicable regulatory standards for IVD manufacturing operations.

The role is responsible for ensuring product quality, process compliance, regulatory readiness, supplier quality, product safety, and continuous improvement throughout the product lifecycle.

2. Key ResponsibilitiesA. Quality Management System (QMS)

Implement, maintain, and continuously improve the Quality Management System in compliance with ISO 13485.
Ensure compliance with company SOPs, quality procedures, GMP, and regulatory requirements.
Manage document control systems including SOPs, records, specifications, forms, and revisions.
Ensure effective implementation of:
CAPA
Change Control
Deviation Management
Risk Management
Non-Conformance Management
Maintain audit-ready documentation at all times.

B. Quality Assurance (QA)

Ensure manufacturing and quality processes comply with approved procedures and specifications.
Review and approve Batch Manufacturing Records (BMR) and quality documents.
Monitor process compliance and shop-floor quality practices.
Ensure line clearance, process validation, and product release activities are performed effectively.
Handle deviations, investigations, and corrective actions.
Conduct internal audits and support external/customer audits.
Ensure implementation of data integrity and documentation compliance practices.

C. Quality Control (QC)

Manage testing and inspection activities for raw materials, in-process samples, and finished goods.
Ensure all QC testing is performed as per approved methods and specifications.
Monitor laboratory practices, calibration, and testing equipment compliance.
Review QC reports and ensure timely release of products.
Investigate Out of Specification (OOS) and Out of Trend (OOT) results.
Ensure laboratory documentation compliance and traceability.

D. Incoming Quality Control (IQC)

Oversee incoming inspection activities for raw materials, consumables, reagents, packaging materials, and components.
Ensure supplier materials meet defined quality standards before release to production.
Coordinate supplier quality issues and material rejection handling.
Maintain incoming inspection records and material traceability.
Support supplier qualification and vendor audit activities.
Monitor supplier quality performance and incoming rejection trends.

E. Risk Management

Lead Risk Management activities as per ISO 14971 requirements for medical devices.
Conduct risk assessments for:
Products
Processes
Equipment
Supplier-related risks
Ensure risk analysis, mitigation, and control measures are properly documented.
Participate in FMEA (Failure Mode and Effects Analysis) activities.
Monitor effectiveness of risk control measures throughout product lifecycle.
Support risk-based decision-making during deviations, CAPA, and change controls.

F. Design & Development Quality

Support Design & Development activities in compliance with medical device regulations and ISO 13485.
Participate in:
Design reviews
Design verification
Design validation
Design transfer activities
Ensure Design History File (DHF) documentation compliance.
Review product specifications, protocols, and validation reports.
Coordinate risk management activities during product development stages.
Ensure proper documentation and traceability for new product development projects.

G. Post Market Surveillance (PMS)

Manage Post Market Surveillance activities for marketed products.
Monitor customer complaints, product feedback, and field performance data.
Conduct complaint investigations and trend analysis.
Support vigilance reporting and regulatory reporting requirements.
Coordinate Field Corrective and Preventive Actions (FSCA/Recall) if required.
Prepare PMS reports and quality trend analysis for management review.
Drive continuous product improvement based on market feedback and complaint analysis.

H. Regulatory & Compliance Management

Ensure compliance with:
ISO 13485
CDSCO Medical Device Rules
Internal SOPs and quality standards
Customer and regulatory audit requirements
Coordinate internal, external, regulatory, and customer audits.
Ensure timely closure of audit observations and CAPA implementation.
Maintain regulatory and quality compliance documentation.

I. Supplier Quality & Vendor Management

Participate in supplier qualification and vendor audits.
Monitor supplier quality performance (QCD – Quality, Cost, Delivery).
Coordinate supplier corrective actions for quality issues.
Maintain Approved Vendor List (AVL) compliance documentation.

J. Cross-Functional Coordination

Coordinate closely with:

Production
R&D
Regulatory Affairs
Supply Chain & Stores
Engineering & Maintenance
Procurement

to ensure product quality, compliance, and operational efficiency.

K. Team Management

Lead and mentor QA, QC, and IQC teams.
Allocate responsibilities and monitor departmental KPIs.
Conduct quality trainings and awareness programs.
Ensure adherence to SOPs, compliance standards, and safety requirements.
Drive accountability and continuous improvement culture.

3. Key Deliverables / KPIs

Successful ISO 13485 and regulatory audit outcomes
Reduction in non-conformances and deviations
CAPA closure effectiveness
Incoming rejection reduction
Product complaint reduction
On-time batch release performance
Supplier quality improvement
PMS effectiveness and complaint closure timelines
Risk mitigation effectiveness

4. Educational Qualification

Bachelor’s Degree in Biotechnology / Microbiology / Pharmacy / Life Sciences / Engineering
Master’s Degree or Quality Certifications preferred

5. Experience

8–12 years of experience in QA/QC within Medical Devices / Pharma / IVD industry
Strong exposure to ISO 13485 and regulatory audits
Experience in Risk Management and Post Market Surveillance preferred

6. Skills Required

Strong knowledge of:
ISO 13485
ISO 14971 Risk Management
Medical Device Regulations
CAPA and audit systems
QC laboratory practices
Validation and documentation systems
ERP knowledge (SAP preferred)
Strong analytical and problem-solving skills
Leadership and team management capability
Excellent communication and coordination skills

7. Behavioral Competencies

High integrity and compliance-focused mindset
Strong attention to detail
Critical thinking and investigation capability
Decision-making under pressure
Continuous improvement approach

8. Special Requirements (IVD Industry Specific)

Understanding of:

IVD manufacturing processes
Reagents, chemicals, and consumables handling
Cleanroom compliance
Product traceability systems
Design Control requirements
PMS and complaint handling systems
Handling ISO / CDSCO / customer audits

9. Authority Matrix

Approval authority for quality documents and product release
CAPA approval and investigation authority
Authority to stop production during critical quality non-compliance
Audit coordination authority
Supplier quality approval participation

10. Reporting & Documentation

Quality KPI reports
CAPA and deviation reports
PMS and complaint trend reports
Audit reports and compliance documentation
IQC/QC reports
Validation and risk management records

11. Working Conditions

Factory-based role with regular shop-floor monitoring
High involvement during audits and inspections
Frequent cross-functional coordination
Occasional vendor/customer audit participation

How to Apply

Interested candidates can reach out directly via:

Email: [email protected] & [email protected]
WhatsApp/Call: +91-9560727259

Job Type: Full-time

Pay: ₹604,055.36 - ₹1,325,355.94 per year

Benefits:

Cell phone reimbursement
Commuter assistance
Food provided
Health insurance
Leave encashment
Paid sick time
Provident Fund

Work Location: In person

Quick apply

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