Giesecke+Devrient GmbH

Lead Engineer- Quality Assurance

Gurugram, IN, United States

Remote
Full-time
29 days ago
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Summary

Objective Of This Role: * Strong background in QMS, PLM and Product certification and compliance. * Knowledge on SDLA (Software Development Life Cycle Architecture) Tasks & Responsibilities: * Develop, implement, and maintain QMS to ensure continuous improvement in product quality and compliance. * Ensure QMS aligns with ISO 9001 and other applicable industry standards and certifications. * Conduct internal audits and assessments to evaluate the effectiveness of the QMS. * Lead root cause analysis and corrective/preventive actions (CAPA) for quality issues. * Train and support teams on QMS processes and standards. * Manage the end-to-end product lifecycle from concept through to production, ensuring all stages align with company standards and regulatory requirements. * Oversee the implementation and management of PLM software tools for streamlined product development, engineering changes, and document control. * Collaborate with cross-functional teams (engineering, operations, design) to ensure product lifecycle stages are managed effectively and efficiently. * Monitor product performance, and feedback and ensure timely modifications and improvements are incorporated. * Ensure compliance with local and international regulations, standards, and certifications (e.g., CE, UL, RoHS, etc.). * Act as the point of contact for regulatory bodies, certification agencies, and external auditors. * Prepare and maintain compliance documentation for product certification, regulatory audits, and inspections. * Identify and assess risks related to product quality, compliance, and certification and develop risk mitigation strategies. * Lead initiatives to proactively address potential product quality or compliance issues before they impact the market. * Promote a culture of continuous improvement in product quality, regulatory compliance, and process optimization. Education & Trainings: * Bachelor's degree in Engineering, Quality Management, or related field. Master's degree is a plus. Technical know how: Mandatory * Proven experience in QMS, PLM, product certification, and regulatory compliance management (5+ years preferred). * Knowledge of quality management standards (ISO 9001), product lifecycle processes, and regulatory frameworks (CE, UL, RoHS etc.) * Excellent problem-solving skills, with a focus on root cause analysis and continuous improvement. * Strong understanding of product certification processes and compliance management in a global market. Good to know * Certifications in Quality Management (e.g., Six Sigma, ASQ, etc.) or Regulatory Affairs. * Experience with product certification processes across multiple industries (electronics, medical devices, automotive, etc.). * Familiarity with advanced PLM and problem solving tools. Soft Skills * Excellent communication, leadership, and interpersonal skills. * Strong attention to detail and organizational skills. Experience (in yrs.) Total 7 ~ 10 Year

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