Job description:

About HCLTech
HCLTech is a global technology company, spread across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. We re powered by our people a global, diverse, multi-generational talent - representing 161 nationalities whose unique spark, perspective and boundless passion drive our culture of proactive value creation and problem-solving.
Our purpose is to bring together the best of technology and our people to supercharge progress for everyone, everywhere our clients, partners, their stakeholders, communities, and the planet. As a company, we are deeply focused on accelerating our ESG agenda. We are also creating technology-enabled sustainable solutions with and for our clients and partners. We embed ESG imperatives into every aspect of our business and ensure that the progress we supercharge is responsible, inclusive and beneficial to all our stakeholders in the long term. We have committed to achieving net zero by 2040.

To learn more about how we can supercharge progress for you, visit www.hcltech.com

Technical lead with mdr,medical - iso13485 process,Process Failure Mode Effect Analy(PFMEA)

Job Summary
The Technical Lead will be responsible for leading the mdr, medical iso13485 process, Process Failure Mode Effect Analy(PFMEA) within the organization. They will oversee the technical aspects related to medical device reporting, ISO 13485 processes, and PFMEA.

• Key Responsibilities
  1. Provide technical leadership and guidance on mdr and medical device regulations.
  2. Implement and maintain iso 13485 processes to ensure compliance.
  3. Conduct process failure mode effect analysis (pfmea) to identify and mitigate risks in processes.
  4. Collaborate with cross functional teams to drive continuous improvement in quality and regulatory processes.
  5. Develop and update standard operating procedures (sops) related to mdr, medical devices, and pfmea.
  6. Train and mentor team members on technical aspects and best practices in medical device regulations.
  
  Skill Requirements
  1. In-depth understanding of mdr regulations and medical device reporting processes.
  2. Proficiency in implementing and managing iso 13485 quality management systems.
  3. Experience in conducting process failure mode effect analysis (pfmea) in a regulated industry.
  4. Strong analytical and problem-solving skills.
  5. Excellent communication and interpersonal abilities to collaborate effectively with diverse teams.
  6. Attention to detail and strong organizational skills to ensure compliance and quality standards are met.
  
  Certifications: Relevant certifications in medical device regulations, ISO 13485, or PFMEA are a plus.