Lead Engineer- Quality Assurance
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
$$ We are an equal opportunity employer! We promote diversity in all its forms and create an inclusive work environment, free from prejudice, discrimination and harassment, in which all employees feel a sense of belonging. We warmly welcome all applications regardless of gender, age, race or ethnic origin, social and cultural background, religion, disability and sexual orientation.
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