CAPA Specialist (Medical Devices)
- Tata Elxsi
- 4 - 12 years
- Pune
- 7 days ago
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Job Description
1. CAPA Specialist
The CAPA Specialist (or Senior Specialist) is the primary "doer" responsible for the technical accuracy and timely completion of individual quality records.
Core Responsibilities:
o Investigation: Lead end-to-end CAPA investigations, including assessing issue descriptions and reviewing performance data.
o Root Cause Analysis (RCA): Perform rigorous RCA using structured methodologies like the 5 Whys, Fishbone (Ishikawa), or Fault Tree Analysis.
o Execution: Define and implement specific corrective/preventive actions and verify their effectiveness through testing.
o Audit Representation: Represent specific CAPA files during internal and external regulatory audits.
Qualifications:
o Education: Bachelors in Engineering or Science (e.g., Biomedical or Electrical Engineering).
o Experience: Typically 37 years in medical device quality (Class II/III preferred).
2. R&D CAPA Manager
The R&D CAPA Manager is a governance role focused on process integrity, systemic trends, and cross-functional alignment.
Core Responsibilities:
o Program Oversight: Own the end-to-end execution of the R&D CAPA portfolio, ensuring all records meet QMS and global regulatory standards (ISO 13485, FDA QMSR, EU MDR).
o Stakeholder Management: Act as the interface between R&D, Quality, and Regulatory Affairs to ensure proper resourcing for quality actions.
o Data Trending: Analyze CAPA data to identify systemic trends and provide insights to improve R&D design and manufacturing processes.
o Process Optimization: Drive the digitalization and optimization of CAPA workflows to improve speed and compliance.
Qualifications:
o Education: Bachelors Degree required; Masters or MBA often preferred for management tracks.
o Experience: Typically 8+ years, with proven experience in leading complex investigations and challenging weak problem statements.
Job Classification
Industry: MiscellaneousFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: Tata ElxsiLocation(s): Pune
Keyskills: CAPA Root Cause Analysis 13485 QMS 14971 Mdr Medical Devices
Tata Elxsi
Wipro Ltd (NYSE:WIT) is a global information technology, consulting and outsourcing company with 170,000+ workforce serving clients in 175+ cities across 6 continents. \r\n\r\nWipro helps customers do business better by leveraging our industry-wide experience, deep technology expertise, comprehensiv...
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