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Senior Quality Systems Engineer

3 months ago

Galway, Ireland TE Connectivity Full time
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 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.

The Senior Quality System Engineer is a member of the Quality Systems department. They are responsible for supporting and leading the organization in its’ drive towards optimum quality compliance to site as well as corporate policies and external regulations, while adhering to efficient and lean principles. This role is responsible for working with the wider organization to ensure the effective and compliant implementation of the site Quality Management System and to prepare the site to demonstrate compliance during regulatory audits. The role will also work across-site to lead and implement projects that will transform the operating practices and systems of this Quality Management System.

This is a 12 month contract for maternity cover. 

Tasks and Responsibilities:

Stay current with quality system standards and requirements.  Provide Quality Systems support for the Galway site. Provide supervision to different subsystems such as Document Control, Training and QS Technicians. Frequently interact with other supervisors and/or peers. Assist in the preparation and maintenance of records associated with the management review process. Develop effective quality metrics and communicate the results to key stakeholders using reports, presentations, and dashboards.  Ensure compliance and drive improvements in QS processes. Participate in Quality Systems projects under the direction of the Quality Systems Manager and/or Head of Quality. Develop and implement processes, procedures, and instruction to sustain and improve the Quality Management System. Support Quality Systems Manager in the development and implementation of quality systems strategies and objectives. Coach and mentor when needed. Work within cross-site teams to implement best practices in methods and systems that drive Quality Excellence within the Quality Systems team on best practice. Lead and maintain Cross-training efforts within QS organization.  This is not an exhaustive list of duties or functions and may not necessarily comprise all the "essential functions".

Qualifications and Experience Required:

Bachelors degree or local equivalent in Engineering / Science / Quality field.  Minimum 5 years of progressively responsible professional level experience. Previous experience at Senior/Supervisory level within the Medical Device or related industry preferred. Must be familiar with all aspects and elements of a quality system, ISO13485; FDA QSR & MDSAP. Must have experience of hosting audits from external regulatory agencies and corporate functions. Experience for leading cross-functional teams would be a benefit. Ability to work independently under general guidelines and supervision and consider options for completing work Proven ability to influence. Excellent attention to detail  Highly organized with strong ability to prioritize tasks and work on own initiative. Trained Auditor ideally lead auditor training and/or experience Effective interpersonal skills as demonstrated through prior supervisory experience. Ability to adapt to changing duties and responsibilities. 

Competencies

Motivating OthersManaging and Measuring WorkBuilding Effective TeamsValues: Integrity, Accountability, Inclusion, Innovation, TeamworkSET : Strategy, Execution, Talent (for managers)