Medical Devices - Quality & Regulatory Specialist
- Citiustech
- 5 - 8 years
- Chennai
- 7 days ago
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Job Description
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.
Job Classification
Industry: Medical Devices & EquipmentFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: CitiustechLocation(s): Chennai
Keyskills: Capa Medical Devices Imaging Radiology
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