QA Engineer with 9+ years in Quality Management Systems & Regulatory Affairs
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Evaluating your skill match against the job requirements…
Assessing your cultural and operational fit
Dedicated Quality Assurance & regulatory affair Specialist with extensive expertise in QMS ISO 13485 Documentation and ensuring high standards of medical device quality and safety. Committed to continuous improvement and excellence in the medical device industry.
St. Josephs Polytechnic College
Diploma · Mechanical Engineering
August 1, 2012 – June 30, 2014
Govt. Technical High School
V.H.S.E · Maintenance and Repair of 2 & 3 Wheeler
June 1, 2010 – May 31, 2012
Govt. Technical High School
T.H.S.L.C · Electrical Wiring & Maintenance of Domestic Appliances
June 1, 2009 – May 31, 2010
Rawand Industries for Medical Products
QA/REGULATORY AFFAIRS
May 1, 2022 – Present
Dammam, Eastern Province, Saudi Arabia
Jayon Implants. Pvt Ltd.
QA/QC
June 1, 2017 – May 1, 2022
Pālghāt, Kerala, India
Saint-Gobain Refractory India. Pvt Ltd.
Quality Control Inspector/ Production
November 1, 2014 – May 1, 2017
Pālghāt, Kerala, India
Basic mechanical drafting
NCVT (National council for vocation training)
June 1, 2026 – Present
Training of 2 & 3 wheeler
Adhithya Auto Sales and Services
June 1, 2026 – Present
Project on 'Over usage reduction in solder blocks' (WCM yellow belt)
Saint-Gobain
June 1, 2026 – Present
NDT (Nondestructive testing) level II
ASNT (American society for nondestructive testing)
June 1, 2026 – Present
Cultural Fit Analysis
The candidate's experience spans multiple companies within the manufacturing and medical device sectors, indicating adaptability to different organizational cultures. Their involvement in WCM (World Class Manufacturing) and continuous improvement projects (5S, Lean Manufacturing) suggests a proactive and improvement-oriented mindset, which aligns well with cultures valuing efficiency and quality. The focus on regulatory compliance and adherence to international standards (ISO, ASTM, SFDA) points to a disciplined and structured work approach. The candidate's educational background in mechanical engineering, while not directly in software QA, provides a foundational understanding of product design and manufacturing processes, which is beneficial in hardware-focused QA roles.
Soft Skills & Operational Fit
The candidate demonstrates strong operational fit for a QA Engineer role, particularly in regulated industries like medical devices. Their experience highlights meticulous attention to detail, adherence to procedures (SOPs), and a proactive approach to quality improvement (CAPA, 5S, Lean Manufacturing). The ability to train junior staff indicates leadership potential and good communication within a team. The candidate's consistent employment history suggests reliability and commitment. However, without specific psychometric test results, a deeper assessment of logical reasoning, stress handling, and team collaboration is not possible.