Job Description

Job Posting Title: SR QLTY & RELIABILITY ENGINEER Job ID: [[id]] Job Code: 30004600 Business Unit: MEDICAL (50126885) Building: Sahasra Shree (N84) Band/Level: 5-2-C Hiring Manager: Elena Garcia Sampedro Recruiter: Hari D R Relocation: No Travel: Less than 10% Education Experience: Other Employment Experience: 7-10 years At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview TE Connectivity\'s Quality Assurance Teams are responsible for all or part of an organization\'s Quality Management System, including conformance and continuous improvement initiatives. They work on systemic evaluation of products, services, facilities, manufacturing or business processes, to ensure that standards of quality are being met. Develop and implement quality plans, programs and procedures using quality control statistics, lean manufacturing concepts, and six-sigma tools and analyses. They reviews, analyze and report on quality discrepancies, investigate problems and executes quality audits, and develops disposition and corrective actions for recurring discrepancies. The team works closely with manufacturing, engineering, customers, or suppliers and subcontractors to ensure requirements are met. The Global Snr Quality Systems Engineer is responsible for supporting the implementation of a Global Audit Program across TE Medical. This role will work closely with site Quality Systems teams to ensure harmonized Quality System processes are implemented and effective, and serve the business, as well as meeting regulatory requirements. This person will support cross-site activities and drive best practice adoption and deployment. Responsibilities: . 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 EOE, Including Disability/Vets

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