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Senior Quality & Reliability Engineer

5.00 to 10.00 Years   Bangalore   05 May, 2023
TE Connectivity India Pvt Ltd
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaService / Installation / Repair
EmploymentTypeFull-time

Job Description

    Be the SME and process owner for the TE Medical Global Audit program and provide the governance and documentation required to implement and run the program.Perform an active role in further development and continuous improvement of the quality management system. Drive harmonization of the internal audit process; work with sites to develop implementation plans, ensure site activities are completed as planned, monitor implementation and effectiveness. Develop and deliver training on harmonized processes as required. Help develop the QMS harmonization strategy; understanding individual sites maturity, compliance risks, other competing activities etc. Organize both scheduled and unannounced Global audits across global sites to ensure regulatory compliance. Liaison with Lead Auditors at the sites to review audit results and implement Audit best-practices across the organization. Work with cross-functional and cross-site teams to improve quality system processes. Implement changes to the QMS as driven by internal and external factors. Participate in Quality System integration and harmonization activities for new sites and businesses as acquired. Drive awareness of current regulatory audit hot-topics by keeping current on external reports and information; share this information globally. Ensure all sites are audit ready . Assists internal audits, leads global audits and follows up actions for customer and notified audits. Provide guidance to the business on QSR/ISO requirements. Takes part in Global Compliance projects defined by the Global QS Compliance team. Reporting directly to the Global Quality Systems Manager Candidate Desired Profile: Bachelor s Degree in science, Engineering, or related subject 5+ years relevant quality systems / quality operations experience in GMP manufacturing environment in Medical Device/Pharma industry Lead Auditor ISO 13485 certification Strong CAPA experience. Strong root cause analytical and problem-solving skills. Strong working knowledge of FDA and ISO Quality systems for medical device companies. Demonstrated expertise in quality concepts, practices, and procedures. Must have a good understanding of quality system requirements and how each quality system element connects. Well organized with strong ability to prioritize tasks and work on own initiative Good written and verbal communication skills. Strong interpersonal skills are required. Working knowledge of regional and international quality system requirements including 21CFR 820 and ISO 13485. Competencies Values: Integrity, Accountability, Teamwork, Innovation,

Keyskills :
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