TE Connectivity
hace 2 días

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.

What your background should look like :

The Senior Operations Quality Engineer is responsible for Operations Quality within their prescribed area of functional responsibility.

The successful candidate will lead and work as part of a team to maintain high quality / performance standards on all Creganna Medical products.

Reporting to the Operations Quality Manager, the position will be challenging and will require an ability to lead a team and work on own initiative and with minimum supervision.

Major Accountabilities :

  • Provide quality input and support to the manufacturing, engineering, prototype and commercial functions.
  • Lead and coordinate preparing & on-going maintenance of FMEAs and Control Plans.
  • Overall responsibility for functional area GMP standards and compliance including the promotion of Quality Awareness.
  • Have a good working knowledge of ISO / FDA / MDD and other Product Development related regulatory requirements
  • Performing and supporting internal and external audits to ISO and FDA requirements.
  • Support Operations area projects and initiatives i.e. Kaizen, CFPS etc.
  • Education and Requirements :

  • Engineering or related Degree
  • English level 90%
  • Minimum of 5yrs industry experience in a medical device-manufacturing environment.
  • Strong CAPA and root cause analytical and problem solving skills.
  • Strong working knowledge of FDA and ISO Quality systems for Medical device companies desirable.
  • New product introduction and manufacturing process transfer experience desirable
  • Competencies Values : Integrity, Accountability,Teamwork, Innovation

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