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Summary:
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The CAPA Specialist is responsible for managing the Corrective and Preventive Action (CAPA) process to ensure compliance with global regulatory requirements and internal quality standards. This role supports cross-functional investigations, drives root cause analysis, and ensures timely and effective resolution of quality issues impacting product safety, performance, and compliance.
The CAPA Specialist will maintain proficiency in standards, regulations and guidance documents to provide continuing awareness on changing requirements and ensure compliance.
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Responsibilities:
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In this section, list out in detail the responsibilties of the position, below are some tips on doing so. Please type over the details and if you need to add additional bullets, just press the enter key.
- Lead and manage CAPA investigations, ensuring thorough root cause analysis and effective corrective/preventive actions.
- Collaborate with cross-functional teams (R&D, Quality, Engineering, Manufacturing, Regulatory, Clinical) to resolve quality issues.
- Maintain CAPA documentation in compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR 2017/745.
- Monitor CAPA effectiveness and ensure timely closure of records.
- Prepare CAPA metrics and reports for management review and regulatory audits.
- Support internal and external audits, including MDSAP and Notified Body inspections.
- Train and mentor team members on CAPA processes and problem-solving methodologies (e.g., 5-Why, Fishbone, A3).
- Participate in continuous improvement initiatives related to quality systems and risk management.
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Essential Functions of the Role**:
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- Ability to travel
- Verbal and written communications, reading, and typing
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Work Experience Requirements
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- Number of Overall Years Necessary: 2-5
- Minimum 2–5 years of experience in CAPA or quality assurance roles within the medical device industry.
- Strong knowledge of global regulatory standards (FDA, ISO, EU MDR).
- Experience with electronic QMS platforms (e.g., Biovia, TrackWise).
- Proficiency in root cause analysis tools and statistical methods.
- Excellent communication, documentation, and project management skills.
- Familiarity with risk management tools (FMEA, Fault Tree Analysis).
- Experience supporting CAPA-related training and certification programs.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
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Education Requirements
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- Bachelor’s Degree in scientific or engineering discipline required. Advanced Degree desired.
- Industry certifications are desirable.
- Problem Solving & CAPA training preferred
- Certified Quality Auditor (CQA) and Certified Quality Engineer (CQE) preferred
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Specialized Skills/Technical Knowledge:
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- Strong problem-solving skills; ability to analyze all aspects of a situation, challenge current methods, identify potential solutions, make informed decisions and implement the best solution in an efficient, timely manner. Ability to apply and cultivate new approaches to problem solving
- Ability to execute strategic initiatives and manage day-to-day deliverables
- Strong oral and written communication skills
- Ability to build, work with, and strengthen relationships with team members in other departments, other sites, outside auditors.
- Demonstrated interest in, and understanding of, industry developments and trends
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Local Specifications (English and Local Language):
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