TE Connectivity’s Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors.
They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment.
Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary.
They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action and customer communication.
What your background should look like :
Develop and implement world class quality processes in the Quality System, in support of business requirements.
As a site matures (such as moving from component manufacturing to finished device manufacturing) lead the development of the site's quality system.
Ensure that all aspects of QMS sites (Management Reviews, Internal Audits and Supplier Management, etc.)
Represent quality in meetings with clients; represent the Global Quality organization and be able to outline the Creganna Quality system and principles as part of business proposals.
Responsible for scheduling, planning, conducting, communicating and reporting on the results of the global internal audit.
Communicate closely with the Project Management Office for NPI / transfers to sites that could affect the QMS, and plan for such changes.
Support the implementation of electronic quality systems.
Serves as a quality approver on Engineering Change Orders (ECOs) / Document Change Orders (DCOs), Training Matrices.
Facilitate improvement teams for quality systems. Provide recommendations to consolidate, standardize, simplify and establish systems that meet ISO, FDA (QSR).
Ensure the applicability of current quality policies, procedures and objectives, staying informed about the latest updates / modifications related to relevant standards and regulations.
Evaluate business objectives, identify opportunities for improvement, and apply scientific methods, statistics, and problem-solving techniques.
Plan and execute projects and team activities to facilitate changes in the quality system.
Create and review quality system documentation.
Act as lead auditor to assess compliance with corporate policies, site procedures, and other applicable regulatory requirements.
Responsible for programming, planning, directing.
Support external audits as needed, which may include assisting with preparation activities, conducting mock audits, supporting front room and back room activities.
Supports change management and organizational strategy across sites
Lead / participate in projects that directly support compliance and / or continuous improvement of sites, departmental and global processes.
Develop solutions for a variety of complex problems of varying scope and complexity where data analysis requires the evaluation of identifiable factors.
Conduct on-site training (PIB, GMP, CAPA, Compliance, etc.)
Thoroughly understand the quality system process for negotiating and challenging root cause.
Maintains a solid understanding of the CAPA system and procedures, drives CAPA compliance, and provides CAPA oversight.
Comply with the company's code of conduct, policies and practices.
Demonstrate computer skills with Microsoft Office (Word, Excel, PowerPoint, and Visio).
Calculate and present KPI metrics. Supervision : Yes Education and Experience :
Title that accredits him for the performance of the position in areas of Engineering or an equivalent discipline.
CQE / CSSBB certification desirable.
5-7 years of minimum experience in similar positions. Qualifications :
Experience in process compliance and auditing.
Manage multiple tasks and accomplish them in a timely manner
Act as a trained Lead Auditor with experience in conducting quality system audits.
Excellent communication and interpersonal skills.
Highly organized with great ability to prioritize tasks and work on initiative.
Ability to evaluate information gathered from observation, experience, reasoning and / or communication. Demonstration of clarity, precision, independent judgment, and thoroughness.
Strong knowledge of ISO and FDA quality requirements.
Based in Costa Rica, but willing to travel up to 20%.
Values : Integrity, Accountability,Teamwork, Innovation