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**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 13485.
- 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 multi-disciplinary 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