Senior Technical Specialist MDR, PFMEA
India
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Job Description
Senior Technical Specialist MDR, PFMEA

Job Summary

As a Senior Technical Specialist focusing on mdr, medical iso13485 processes, and Process Failure Mode Effect Analysis (PFMEA), your primary responsibilities will include ensuring compliance with ISO 13485 standards, driving the implementation of mdr regulations, and leading the PFMEA process to mitigate potential risks in medical device manufacturing.

Key Responsibilities

1. Oversee and maintain adherence to iso 13485 standards in all relevant processes and documentation.
2. Implement and monitor compliance with mdr regulations related to medical device development and manufacturing.
3. Lead and conduct process failure mode effect analysis (pfmea) to identify and address potential failure modes and risks in the manufacturing process.
4. Collaborate with cross functional teams to implement corrective and preventive actions based on pfmea findings.
5. Drive continuous improvement initiatives to enhance the reliability and quality of medical devices manufactured.

Skill Requirements

1. In-depth knowledge of mdr regulations and iso 13485 standards.
2. Proficiency in conducting process failure mode effect analysis (pfmea) in a medical device manufacturing setting.
3. Strong analytical skills to assess risks, define mitigation strategies, and drive process improvements.
4. Excellent communication and collaboration abilities to work effectively with multidisciplinary teams.
5. Problem-solving mindset and ability to make data driven decisions to ensure compliance and quality standards.

Other Requirements

1.Relevant certifications in Quality Management Systems and Medical Device Regulations would be a plus.
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Information at a Glance

Why HCLTech?

At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.

HCLTech is a global technology company, home to more than 226,600 people 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. Consolidated revenues as of 12 months ending September 2025 totaled $14.2 billion.
23 Benefits At HCLTech, we believe in empowering our employees with comprehensive benefits that support their professional growth and enhance their well-being. When you sign up for a career with us, you gain access to: https://rmkcdn.successfactors.com/147eb21f/a701dca9-f32d-4fc9-9447-6.svg Industry-benchmarked compensation https://rmkcdn.successfactors.com/147eb21f/b0c54381-ddcc-4a33-9b35-9.svg Best-in-class healthcare benefits https://rmkcdn.successfactors.com/147eb21f/b73027be-7aae-4d36-a090-4.svg Personal time off https://rmkcdn.successfactors.com/147eb21f/d5b4fdfd-2e99-4e26-9878-9.svg Maternity and paternity benefits https://rmkcdn.successfactors.com/147eb21f/3d42b0fc-4652-435a-9ece-c.svg Access to skills / higher education programs/resources https://rmkcdn.successfactors.com/147eb21f/aeddeaf2-9e25-4584-ad11-d.svg Discounts on products and services via Benefit Box https://rmkcdn.successfactors.com/147eb21f/a9609a3b-2700-4b3c-9d90-a.svg Participate in CSR programs and live life with a purpose https://rmkcdn.successfactors.com/147eb21f/c6e33851-710f-4634-bd69-f.svg Opportunities to grow and advance your career Note: The benefits listed above vary depending on the nature of your employment and the country where you work. Some benefits may be available in some countries but not in all.