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 OverviewThe Quality Systems Lead is the Quality Systems Representative for this location. This role is responsible for ensuring that all quality-related activities are being performed according to the QMS procedures and must have a working knowledge of Quality Assurance and Quality Control. Onsite role, with potential to go hybrid after 6 months.ResponsibilitiesQuality Systems Lead and Quality Representative for the siteCollaborate to ensure the relevance of the Quality Policy and the Quality ObjectivesWork with Management to ensure that the proper resources are available to conduct QMS activitiesOversee NCR, Complaint, and CAPA systems to ensure proper disposition of non-conforming materials, root cause determination, and corrective/preventive actionsEvaluate suppliers for ability to provide needed materials/services including supplier auditsManage instrumentation and equipment used for inspections and V&V activitiesMaintain records needed to demonstrate conformance to the standardsConduct Quality Management Reviews to ensure the effectiveness of the QMS in accordance with ISO 13485 standards and applicable regulatory requirementsPerform document control activities ensuring the most current revisions are available while segregating and storing previous revisionsParticipate in the Internal Audit programActs as a Quality Representative during external audits (customer and notified bodies)Promote quality as culture throughout the site and the organizationWork collaboratively across site functions and with all levels of the organizationConsult on new product development projects regarding quality related questions and ensure that project documents are managed properlySupport Verification & Validation and Design Transfer activitiesCollaborate with manufacturing/operations to develop receiving inspections, in-process inspections, and final acceptance testing for process development projectsWhat your background should look likeBachelor's Degree and minimum 8 years of related work experience (Master's Degree preferred)Experience working in a team environmentCurrent working knowledge of ISO 13485 Quality Management Systems and FDA 21 CFR 820 strongly preferred
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