Technical Lead
4 weeks ago
Looking for Immediate joiners - From 3+ to 10 yrs :- Key responsibilities Validation Gap Analysis : Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices. Deviation Investigation and Resolution : Investigate deviations encountered during IQ, OQ, and PQ processes, determine root causes, and recommend corrective and preventive actions (CAPAs). Protocol and Reports Review : Review IQ, OQ, and PQ protocols and reports for equipment, utilities, and facilities, ensuring adherence to regulatory and internal requirements. Cross-Functional Collaboration : Collaborate with engineering, production, quality assurance, and other teams to coordinate qualification activities and ensure successful project outcomes. Documentation and Record Management : Review complete validation documentation, including risk/impact assessments, change-control records, and deviation reports. Continuous Improvement : Identify and propose remediation actions for existing and potential validation issues, driving continuous improvement initiatives. Staying Current: Check for up-to-date validation requirements, best practices, and industry trends related to medical device IQ, OQ, and PQ. Qualifications/ JD: Bachelor‘s degree in Mechanical / Biomedical / SW /HW Engineering , Quality Assurance, Regulatory Affairs, or a related field. Experience: 3-5+ years of experience in validation within the medical device industry, with a focus on IQ, OQ, and PQ activities. Regulatory Knowledge: Strong understanding of medical device regulations, including FDA 21 CFR Part 820 and ISO 13485. Validation Expertise: In-depth knowledge of validation methodologies, including IQ, OQ, and PQ for equipment, utilities, and processes. Risk Management: Familiarity with risk assessment methodologies (e.g., FMEA) and their application in validation activities. Communication Skills: Excellent written and verbal communication skills to effectively convey information to internal and external stakeholders, including auditors and regulatory agencies. Analytical and Problem-Solving Skills: Strong analytical abilities to identify gaps, interpret data, and propose effective solutions. Attention to Detail: Meticulous attention to detail for reviewing documentation and ensuring compliance. Teamwork and Collaboration: Proven ability to work effectively in a cross-functional team environment. Documentation Skills: Proficiency in creating and reviewing technical documentation, protocols, and reports. Software Proficiency: Familiarity with relevant software tools and platforms used in validation activities (e.g., Quality Management Systems, statistical analysis software). Qualifications & Skills Education: Bachelor‘s degree in Biomedical, Mechanical, Software, or Hardware Engineering, or in Regulatory Affairs or Quality Assurance. Experience: 5–10 years in medical device risk assessment, validation, or DHF remediation. Technical Proficiency: ISO 14971, ISO 13485, FDA 21 CFR Part 820 Tools like DOORS, Polarion, TrackWise, SAP PLM Familiarity with AI/ML-based SaMD and cybersecurity frameworks If interested, please share the resume to along with below required details. Experience - CTC- Notice Period- Native - Current Location - Regards PrasenakumarGP Note - **Irrelevant profiles will not be considered for this opportunity.
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