Staff Quality Engineer

hace 2 semanas

Juárez, Chihuahua, México Johnson & Johnson A tiempo completo

Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.

Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.

We are searching for the best talent for STAFF QUALITY ENGINEER to be in Juarez, Chih., in Plant Salvarcar.

Purpose:

Responsible for quality engineer activities for existing and new medical device technologies developed at Coherex Medical. This includes the management of projects as assigned. It requires interfacing with R&D and Manufacturing engineers and other staff members.

You will be responsible for:

Under (e.g. limited supervision, general direction, etc.)
and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

  • Perform the work of Quality Engineering such as development PQ validation protocols, execution and report writing.
  • Perform Quality Systems support in areas of Inspection, MRB, Calibration, CAPA's PM's Internal Auditing, Supplier Qualification & Auditing, Customer Complaints, & Post Market Surveillance.
  • Work with R&D and Manufacturing engineers to identify opportunities for improvement and validation of processes.
  • Identify requirements for ensuring conformance of product to specifications and ensure requirements are met.
  • Develop/write and maintain documentation that defines the company's quality engineering procedures
  • Hands on involvement in company's validation programs for existing and new manufacturing processes.
  • Application of process controls and the assessments and communications of data acquired from process measurements systems.
  • Identify tools and methods required to ensure product compliance to specifications and process robustness.
  • Manage the quality engineering activities for the company.
  • Interface with other departments within the company to integrate the quality engineering activities with other company objectives and priorities.
  • Ensure that essential regulatory requirements are met during quality engineering activities
  • Perform other related duties and tasks, as needed.
  • Responsible for communicating business related issues or opportunities to next management level
  • Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed

Qualifications:

Qualifications and requirements:

  • Bachelor of Science in Engineering preferably Mechanical or Manufacturing engineering
  • Strong knowledge of the medical device industry.
  • A strong knowledge of quality and regulatory systems including FDA's Quality System Regulation and ISO 1348
  • Must be able to read, write and verbally communicate effectively in English.
  • A minimum of five years of quality engineering or closely related experience in the medical device industry.
  • Experience with project planning and management tools.
  • Demonstrated experience managing projects requiring multidisciplinary inputs
  • Ability to handle multiple priorities/projects in an effective manner.
  • Excellent written and verbal communication skills.
  • Strong interpersonal skills and the ability to communicate effectively with others.
  • Excellent organizational skills.
  • Strong technical writing skills.
  • Knowledge and practice of statistics for validation

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