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Sr. QA Associate - Medical Devices (ISO13485) - Job Opportunity at PathnSitu Biotechnologies Pvt Ltd

Medchal, India
Full-time
Senior
Posted: March 26, 2025
On-site
INR 8,00,000 - 12,00,000 per annum based on experience and qualifications in the Indian medical device sector

Benefits

Indian statutory benefits (PF, ESI, etc.)
Medical device industry exposure
Professional development in quality systems
ISO compliance experience

Key Responsibilities

Lead quality assurance policy development and implementation for medical devices
Direct testing and inspection protocols for materials and finished products
Manage internal audit processes and documentation systems
Drive quality system improvements through data analysis
Coordinate quality training programs and interventions
Handle customer complaint investigations and non-conformance resolution
Oversee document management systems and compliance procedures

Requirements

Education

Masters degree or Bachelors in Biotechnology/Biochemistry/Microbiology or life science

Experience

Experience in ISO, USFDA, CE, and IVD documentation

Required Skills

Quality assurance policy development Internal auditing Documentation management English proficiency (written and verbal) Quality system implementation Regulatory compliance Data analysis

Certifications

ISO 13485 knowledge preferred Additional regulatory certifications beneficial
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Industry Trends

Medical device quality assurance is experiencing increased regulatory scrutiny globally, particularly in emerging markets like India The convergence of traditional medical devices with digital health solutions is creating new quality control challenges Growing emphasis on risk-based approaches in quality management systems

Role Significance

Typically leads a team of 3-5 QA associates in medical device manufacturing settings
Senior position with significant influence on product quality and regulatory compliance outcomes

Key Projects

Implementation of ISO 13485 quality management systems USFDA compliance preparation and maintenance Quality system digitalization initiatives Supplier quality management programs

Success Factors

Strong understanding of international medical device regulations Ability to balance quality requirements with operational efficiency Excellence in documentation and process validation Strong stakeholder management skills across departments

Market Demand

High demand due to expanding medical device manufacturing in India and increasing regulatory requirements

Important Skills

Critical Skills

ISO 13485 quality management system expertise Documentation and record-keeping excellence Regulatory compliance knowledge Quality control methodology expertise

Beneficial Skills

Project management capabilities Statistical analysis skills Risk management expertise Digital quality management system experience

Unique Aspects

Opportunity to work with both ISO and FDA quality systems
Experience in growing medical device market in India
Exposure to international quality standards implementation

Career Growth

2-3 years in current role before advancement, depending on business growth and regulatory project success

Potential Next Roles

Quality Management System Head Regulatory Affairs Director Operations Quality Director Compliance Manager

Company Overview

PathnSitu Biotechnologies Pvt Ltd

PathnSitu Biotechnologies is an emerging player in the Indian medical device and biotechnology sector

Growing presence in the medical device quality assurance space with focus on international standards
Significant presence in Andhra Pradesh with potential for expansion in other Indian markets
Professional environment with emphasis on regulatory compliance and quality excellence
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