Job title: Primary QMS CAPA Lead
About Us
Vaisesika is an ISO 27001 certified innovative and value driven company in the business of Software Development, Quality Engineering, Validated Testing, ERP services, Cloud Migration & DevOps, RPA, Data Analytics & Business Intelligence. We have offices in USA, Canada, India and UAE. We have been able to work in multiple projects in various domains ranging from Healthcare & Lifesciences, BFSI, e-commerce, Retail and we pride ourselves as one of the industry leaders in these areas.
Responsibilities
Ø Serve as the Subject Matter Expert (SME) for CAPA processes, providing guidance on investigations, root cause analysis, corrective actions, and regulatory expectations.
Ø Lead and support QMS remediation initiatives related to CAPA, addressing compliance gaps and strengthening system-level quality processes.
Ø Oversee execution of CAPA remediation activities, ensuring corrective actions are effective, sustainable, and aligned with regulatory requirements.
Ø Conduct and support root cause analysis, risk assessments, and effectiveness checks to ensure corrective actions address systemic issues.
Ø Implement and monitor interim controls and risk mitigation measures during remediation investigations to maintain compliance and product safety.
Ø Develop and maintain CAPA metrics, dashboards, and reporting mechanisms to monitor remediation progress and identify systemic trends.
Ø Provide training, mentorship, and cross-functional guidance to strengthen CAPA process adherence and continuous improvement across the organization.
Ø Bachelor’s degree in a technical or scientific field, or equivalent experience in quality systems within a regulated industry.
Ø 8+ years of experience in Quality Management Systems, preferably within the medical device industry.
Ø Deep expertise in CAPA processes, investigations, and remediation, including experience addressing regulatory observations or audit findings.
Ø Strong knowledge of medical device regulatory requirements, including FDA 21 CFR 820 and ISO 13485.
Ø Proven experience leading cross-functional remediation initiatives or quality system improvement programs across multiple sites or business units.
Ø Strong analytical, problem-solving, and technical writing skills, with the ability to develop regulatory-ready documentation and reports.
Ø Excellent communication and leadership skills, with experience presenting to senior leadership and guiding teams in complex quality and compliance initiatives.
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