Quality consultant - Life Sciences

NTT DATA, Inc.; Hyderabad; Vor Ort; INR 2.600.000 - 4.200.000; Vollzeit

Zusammenfassung

NTT DATA is seeking an experienced Quality consultant to manage supplier quality activities across a global supplier network in Hyderabad. The role focuses on supplier qualification, auditing, risk management, CAPA oversight, compliance monitoring, and continuous improvement within life sciences.

You will collaborate with Procurement, Manufacturing, Operations and Regulatory teams to ensure supplier quality and regulatory compliance, travel domestically and internationally as needed.

Qualifikationen

• Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field.
• 10-12 years of experience in Supplier Quality, Quality Assurance, or Quality Management within Medical Devices, Diagnostics, Pharmaceuticals, or Life Sciences.
• Hands-on experience in supplier qualification, supplier audits, CAPA management, and supplier performance monitoring.
• Strong knowledge of ISO 13485, FDA QSR, EU MDR, Supplier Controls, Risk Management, and QMS.
• Excellent analytical, stakeholder management, communication, and problem-solving skills.
• Willingness to travel domestically and internationally.

Aufgaben

• Plan, conduct, and report supplier audits (on-site and remote) for critical suppliers and contract manufacturers.
• Lead supplier qualification, onboarding, monitoring, and requalification activities.
• Assess supplier Quality Management Systems (QMS) against ISO 13485, FDA QSR, EU MDR, and applicable regulations.
• Drive supplier quality investigations, CAPA implementation, and effectiveness reviews.
• Perform supplier risk assessments and develop mitigation/remediation plans.
• Monitor supplier performance metrics and drive continuous improvement initiatives.
• Collaborate with Procurement, Manufacturing, Operations, Quality, and Regulatory Affairs teams to ensure supplier compliance.
• Identify supplier compliance risks and support regulatory inspections and audits.
• Manage supplier quality issues and ensure timely resolution.

Kenntnisse

Supplier Quality Management

Supplier Audits

Supplier Qualification

CAPA Management

QMS

Regulatory Compliance

Risk Assessment

Quality Assurance

Life Sciences

Continuous Improvement

Ausbildung

Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field

Jobbeschreibung

NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization.

We are currently seeking a Quality consultant - Life Sciences to join our team in Hyderabad, Telangana (IN-TG), India (IN).

Quality Consultant - Quality consultant

Job Summary

NTT DATA is looking for an experienced Quality consultant to manage supplier quality activities across a global supplier network. The role focuses on supplier qualification, auditing, risk management, CAPA oversight, compliance monitoring, and continuous improvement within the Medical Devices, Diagnostics, Pharmaceuticals, and Life Sciences industries.

Key Responsibilities

• Plan, conduct, and report supplier audits (on-site and remote) for critical suppliers and contract manufacturers.
• Lead supplier qualification, onboarding, monitoring, and requalification activities.
• Assess supplier Quality Management Systems (QMS) against ISO 13485, FDA QSR, EU MDR, and applicable regulations.
• Drive supplier quality investigations, CAPA implementation, and effectiveness reviews.
• Perform supplier risk assessments and develop mitigation/remediation plans.
• Monitor supplier performance metrics and drive continuous improvement initiatives.
• Collaborate with Procurement, Manufacturing, Operations, Quality, and Regulatory Affairs teams to ensure supplier compliance.
• Identify supplier compliance risks and support regulatory inspections and audits.
• Manage supplier quality issues and ensure timely resolution.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field.
• 10-12 years of experience in Supplier Quality, Quality Assurance, or Quality Management within Medical Devices, Diagnostics, Pharmaceuticals, or Life Sciences.
• Hands-on experience in supplier qualification, supplier audits, CAPA management, and supplier performance monitoring.
• Strong knowledge of ISO 13485, FDA QSR, EU MDR, Supplier Controls, Risk Management, and QMS.
• Excellent analytical, stakeholder management, communication, and problem-solving skills.
• Willingness to travel domestically and internationally.

Preferred Qualifications

• Certified Lead Auditor (ISO 13485 and/or ISO 9001).
• ASQ CQA, CQE, or equivalent quality certifications.
• Experience managing global supplier networks and contract manufacturing organizations.
• Experience leading supplier remediation and continuous improvement programs.

Key Skills

Supplier Quality Management, Supplier Audits, Supplier Qualification, ISO 13485, FDA QSR, EU MDR, CAPA Management, Supplier Risk Assessment, QMS, Compliance Auditing, Supplier Performance Management, Quality Assurance, Medical Devices, Pharmaceuticals, Diagnostics, Life Sciences, Continuous Improvement

About NTT DATA

NTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners.NTT DATA is a part of NTT Group, which invests over $3 billion each year in R&D.

Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com, @nttdatafed.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form, https://us.nttdata.com/en/contact-us .

NTT DATA endeavors to make https://us.nttdata.com accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at https://us.nttdata.com/en/contact-us . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click here . If you'd like more information on your EEO rights under the law, please click here . For Pay Transparency information, please click here .

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