| Job Title | Mechanical Engineer |
|---|---|
| Category | Engineering |
| Location | Madurai |
| Company | HCLTech |
| Description | Job description Mechanical Engineer with with relative experience in handling Change control documents through SAP/PLM, preferably in the medical device or pharmaceutical industries. Experience understanding and generating engineering documentation in accordance with accepted drafting standards and procedures. Proficient in developing and updating self on the software updates and Process on need basis Demonstrated ability to improve and provide suggestions to update, customise SAP and its related sub modules continuously. Effective communication across functions and within business leadership is a MUST to have skill. Experienced in planning, leading and executing the projects within a cross functional team environment Self-initiator, results driven and action & detail oriented Knowledge of Medical device regulations and practice is a plus Excellent interpersonal, communication, influencing skills Proven ability to quickly learn new subject matter. OR Qualifications/ JD: Bachelor's degree in Mechanical, Quality Assurance, Regulatory Affairs, or a related field. Experience: 1 to 1.5 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. Proven experience in medical device DHF / MDR assessment and remediation. 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. Align risk assessment activities with global regulatory frameworks including FDA QSR, ISO 13485, EU MDR, and IEC standards Conduct risk assessments using methodologies like FMEA, ISO 14971, and hazard analysis. Develop and maintain Risk Management Files (RMF) in compliance with ISO 13485, ISO 14971, and FDA 21 CFR Part 820 Ensure design control compliance throughout the remediation process. Collaborate with cross-functional teams to update legacy documentation and align with current regulatory standards. Review and update D-FMEA and P-FMEA documents for accuracy and completeness Participate in design reviews and lifecycle management to ensure risk controls are implemented effectively 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. |
| Salary | Not Disclosed |
| Last Date | 2026-05-31 00:00:00 |
| Apply Link | Click Here |
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