Senior Quality Lead / Senior Engineer / Assistant Manager Quality As

Role & responsibilities

Senior Quality Lead / Senior Engineer / Assistant Manager Quality Assurance

Key Responsibilities:

• Prepare, review, and maintain QMS documentation in line with ISO 13485.
  
• Conduct root cause analysis of non-conformances and implement CAPA.
  
• Support regulatory and certification audits (ISO 13485, CE, US FDA, etc.).
  
• Conduct internal audits and ensure timely closure of findings.
  
• Facilitate management review meetings and prepare related documentation.
  
• Maintain Design History Files (DHF) and Device Master Records (DMR).
  
• Review and validate engineering change requests (ECR/ECN).
  
• Lead validation/verification activities for processes, jigs/fixtures, and software.
  
• Participate in design reviews and support new product introductions (NPI).
  

• Ensure compliance with NABL 17025, EU MDR, US FDA, and IMDR.

• Administer DMS tool and support product registration in domestic & international markets.
  
• Conduct supplier qualification, process audits, and product risk assessments.
  

Mandatory Qualifications:

• B.E / B.Tech / Diploma in Mechanical, Electrical, Biomedical, or Industrial Engineering.
  
• Alternatively, Postgraduate degree in Engineering, Medical Physics, Regulatory Affairs, or Quality Management.
  
• Strong knowledge of

  ISO 13485, ISO 14971, IEC 62304

  , and

  NABL 17025

  .
• Experience in technical documentation, QMS, statistical tools, validations, and internal audits.
  

Professional Skills:

• Strong documentation and QMS implementation experience.
  
• Proficiency in 7QC tools, calibration, verification, and process control.
  
• Familiar with CE marking, FDA regulations, and EU MDR compliance.
  
• Experience handling audit findings and regulatory submissions

Preferred candidate profile

ISO 13485, ISO 14971, IEC 62304

Interested candidates are encouraged to apply immediately or within 15 days of their notice period vijayakumar.ramachandran@innvolution.com