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