Title/Designation: Specialist/Lead

Role: Quality & Regulatory Specialist - Medical Devices

Exp: 5 to 8 years

Location: Navi Mumbai/ Pune/ Bangalore/ Chennai/ Hyderabad

Job Summary:

The role involves managing Corrective and Preventive Actions (CAPA), ensuring compliance with healthcare regulations, and supporting quality improvement initiatives across imaging and clinical systems. We are looking for a detail-oriented CAPA Engineer with experience in the healthcare industry, particularly in radiology workflows and DICOM standards.

Role & responsibilities:

• Lead CAPA investigations from issue identification through root cause analysis to resolution and effectiveness checks.
• Apply structured problem-solving methodologies (e.g., Fishbone, 5 Whys).
• Collaborate with cross-functional teams including Radiology IT, Product owners/managers. Clinical Engineering, and Regulatory Affairs.
• Ensure CAPA documentation complies with standards such as 21 CFR Part 820, ISO 13485, ISO 14971, and HIPAA.
• Support audits and inspections by regulatory bodies and internal quality teams.
• Analyze trends in non-conformances and CAPA data to identify systemic issues.
• Provide guidance on DICOM standards, PACS/RIS workflows, and interoperability issues in radiology systems.
• Develop and deliver CAPA process training to internal teams.
• Maintain awareness of evolving healthcare regulations and imaging standards.

Required Qualifications:

• 5 - 8 years of experience in a quality or regulatory role within the healthcare or medical device industry.
• Hands-on experience with radiology workflows, DICOM, and imaging informatics.
• Strong understanding of FDA, ISO, and HIPAA regulations.
• Proficiency in quality tools and systems (e.g., QMS platforms, CAPA tracking software).
• Excellent communication and documentation skills.

Preferred candidate profile:

• Bachelors degree in biomedical engineering, Quality Engineering, or related field.
• Experience with DICOM viewers and associated software platforms.
• Certification in Six Sigma, CQE, or similar quality methodologies.
• Familiarity with IHE profiles and HL7 standards.

Our Mission:

At CitiusTech, we constantly strive to solve the industry\'s greatest challenges with technology, creativity, and agility. With over 8,500+ healthcare technology professionals worldwide, CitiusTech powers healthcare digital innovation, business transformation, and industry-wide convergence for over 140 organizations through next-generation technologies, solutions, and products.

We aim to accelerate the transition to a human-first, sustainable, and digital healthcare ecosystem with the world\'s leading Healthcare and life sciences organizations and our partners. Here is an opportunity for you to make a difference and collaborate with global leaders to shape the future of healthcare and positively impact human lives.