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Quality Engineer with 5+ years in Medical Device Manufacturing
Quality Engineer with over 5 years of hands-on experience in medical device manufacturing, supporting Class I and Class II devices within regulated Canadian and global markets. Possesses strong working knowledge of Health Canada Medical Device Regulations (CMDR), FDA 21 CFR Part 820, ISO 13485:2016, and ISO 14971, ensuring full compliance within GMP environments. Experienced in managing CAPA, nonconformances (NCRs), deviations, complaints, and change control processes (ECR/ECO), while actively contributing to process and equipment validation activities including IQ, OQ, and PQ. Proven ability to support high-volume manufacturing operations without compromising regulatory or quality standards. Adept at cross-functional collaboration with Manufacturing, Engineering, Supply Chain, and Regulatory Affairs teams to drive operational excellence. Experienced in conducting internal and supplier audits, supporting regulatory inspections, and maintaining strong audit readiness. Skilled in data-driven quality analysis using SPC, trend analysis, and structured root cause methodologies to enable continuous improvement and risk-based decision-making. Recognized for strong ownership, attention to detail, and a practical, compliance-focused quality mindset.
Chaitanya Bharathi Institute of Technology
Bachelor of Engineering · Mechanical Engineering
N/A – June 30, 2018
University of Ottawa
Masters · Advanced Materials and Manufacturing
N/A – June 30, 2024
Kingstec Technologies Inc
Quality Engineer
September 1, 2024 – Present
Mississauga, Ontario, Canada
Intellijoint Surgical
Quality Engineer
January 1, 2022 – August 1, 2024
Toronto, Ontario, Canada
Meril Life
Quality Engineer
January 1, 2019 – August 1, 2020
Ahmedabad, Gujarat, India
Cultural Fit Analysis
The candidate has worked in diverse geographical locations (India, Canada) and different company sizes within the medical device sector, indicating adaptability. Their experience across multiple companies (Meril Life, Intellijoint Surgical, Kingstec Technologies Inc) suggests a breadth of exposure to various QMS implementations and manufacturing environments. The consistent focus on medical devices and regulatory compliance shows a strong alignment with the specialized nature of the industry, which is beneficial for cultural integration into a highly regulated environment.
Soft Skills & Operational Fit
The candidate demonstrates strong ownership, attention to detail, and a compliance-focused quality mindset, which are critical for a Quality Engineer role. Their experience in cross-functional collaboration, training personnel, and acting as a quality point of contact indicates good interpersonal and leadership potential. The consistent focus on continuous improvement and data-driven decision-making aligns well with operational excellence.