.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 The Quality Analyst / 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. Candidates from all industries are invited to apply.Responsibilities: Quality Systems Lead and Quality Representative for the site.Collaborate to ensure the relevance of the Quality Policy and the Quality Objectives.Work with Management to ensure that the proper resources are available to conduct QMS activities.Oversee NCR, Complaint, and CAPA systems to ensure proper disposition of non-conforming materials, root cause determination, and corrective/preventive actions.Evaluate suppliers for ability to provide needed materials/services including supplier audits.Manage instrumentation and equipment used for inspections and V&V activities.Maintain records needed to demonstrate conformance to the standards.Conduct Quality Management Reviews to ensure the effectiveness of the QMS in accordance with ISO 13485 standards and applicable regulatory requirements.Perform document control activities ensuring the most current revisions are available while segregating and storing previous revisions.Participate in the Internal Audit program.Act as a Quality Representative during external audits (customer and notified bodies).Promote quality as a culture throughout the site and the organization.Work collaboratively across site functions and with all levels of the organization.Consult on new product development projects regarding quality-related questions and ensure that project documents are managed properly.Support Verification & Validation and Design Transfer activities.Collaborate with manufacturing/operations to develop receiving inspections, in-process inspections, and final acceptance testing for process development projects.What your background should look like: Bachelor's Degree and minimum 5 years of related work experience (Master's Degree preferred). Experience working in a team environment. Current working knowledge of ISO 13485 Quality Management Systems and FDA 21 CFR 820 strongly preferred. Strong MS Excel and Word experience. Excellent analytical skills. Must continually seek improvement and effect change in the operating systems. Ability to communicate effectively through email, instant messaging, and verbal methods. Ability to work individually and in a team environment.Competencies Values: Integrity, Accountability, Inclusion, Innovation, Teamwork
