We are seeking a motivated
QA/RA Engineer to support the implementation, maintenance, and improvement of our Quality Management System (QMS) in compliance with global standards and regulations (ISO 9001, ISO 13485, IEC 62304, MDR). In this role, you will collaborate with cross-functional teams to manage documentation, assist in audits, support regulatory submissions, and promote a strong culture of quality across the organization. This position is ideal for candidates with
1–3 years of experience in quality assurance and regulatory affairs who are looking to expand their expertise and grow into a key contributor to compliance and business success.
Key Responsibilities
- Support in implementing, maintaining, and improving the QMS as per ISO 13485, ISO 9001, Indian MDR 2017, applicable standards and regulatory requirements.
- Manage and control documents including version control and distribution.
- Support in Engineering Change management (ECR/ECO process) and ensure compliance to procedures
- Record, investigate, and track Nonconformances (NCs) raised across departments.
- Support Root Cause Analysis and CAPA processes.
- Follow up with responsible teams to ensure timely closure of actions and effectiveness verification
- Prepare, coordinate, and support internal audits and external audits (ISO certification, regulatory audits, customer audits).
- Assist in maintaining audit readiness and ensure compliance with requirements.
- Provide assistance in preparing and maintaining technical documentation for regulatory submissions.
- Stay updated on changes in standards and regulatory requirements applicable to company products
- Collect, analyze, and present quality performance data (NC trends, CAPA status, audit findings).
- Prepare reports for Management Review Meetings (MRM) and support decision-making through data insights
- Assist in planning and conducting QMS trainings for employees on SOPs, CAPA, NC handling, and regulatory compliance.
- Promote a quality culture across teams through regular engagement and awareness sessions
- Work closely with R&D, Production, and Procurement to ensure compliance throughout the product lifecycle.
- Participate in design reviews, risk management activities (ISO 14971), and process improvements
Required Skills
- Strong knowledge of ISO 13485, ISO 9001, ISO 14971, and Indian MDR 2017
- Hands-on experience with quality data analysis, metrics tracking, and report generation
- Competence in Nonconformance handling, CAPA management, and Root Cause Analysis tools
- Strong skills in Document Control (SOPs, Work Instructions, Records) and version management
- Familiarity with Internal Audits and Audit preparedness (ISO, Regulatory, Customer Audits)
- Experience in Engineering Change Management (ECR/ECO process)
- Awareness of medical device safety standards (IEC 60601-1, IEC 60601-1-2, etc.)
- Strong analytical and problem-solving skills for quality investigations
- High attention to detail and accuracy
- Effective communication and interpersonal skills
- Strong time management and organizational skills
- Adaptability and ability to work effectively with cross-functional teams (R&D, Production, Procurement)
- Skilled in report writing and presentation
Qualifications : B.Tech in Biomedical / Electronics / Electrical / related field
Experience: 1 - 3 Years
Job Location : Thiruvananthapuram
Skills: regulatory submissions,capas,quality management systems (qms),iso 9001,technical files,audit management,auditing,root cause analysis,iso 13485,indian mdr,qms,iso 14971,capa/nc investigation methodologies,iso,medical device regulations,fda,regulatory documentation,documentation,data analysis
