Sr Quality Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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Job Description:

We are searching for the best talent for Senior Quality Engineer to be in Ciudad Juarez, Chih.

Purpose:

Under the direction of Quality Operations Lead and with the objective of mai taining high quality standards for the product manufacturing process and compliance with regulatory requirements, administers Finished Goods Quality technicians and/or Quality Engineering technicians to support the Supply Chain i cluding Project support, in day to day activities as failure investigation and data analysis, supporting manufacturing lines, operator certification program, incoming and finished good inspections, and CME environmental monitoring, all in accordance with applicable regulations and Ethicon written specifications and quality standards.

You will be responsible for:

• Identifies improvement opportunities for Quality Engineering Supply Chain project plans, key milestones, and objectives, to ensure deliverables are aligned with customer’s operational needs and requirements.
• Identifies, under limited supervision, any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
• Examines capital and expense forecasts for assigned Quality Engineering projects, to ensure outputs adhere to quality, safety, and regulatory compliance requirements.
• Performs process validations on current and new Quality Engineering processes for subsequent operational integration and supply chain implementation.
• Facilitates supervision of Quality Engineering Technicians by supporting and enforcing site-specific safety and industrial hygiene requirements.
• Communicates and escalates in a timely manner, any Quality Engineering issues or concerns to the next management level.
• Coaches more junior colleagues in techniques, processes, and responsibilities.
• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

Qualifications / Requirements:

• Bachelor’s Degree. Highly Recommended technical field.
• From 4-6 years related experience.
• Experience working in both an FDA and European regulatory environment is preferred.
• Experience with implementation of risk mitigation is preferred.
• Knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• The ability to perform "hands on" troubleshooting and problem solving is preferred. Decision making based on standards, requirements, procedures and quality knowledge gained with experience.
• Basic communication of quality issues, escalations and investigations to different levels.
• Good technical understanding of manufacturing equipment and processes is required.
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred
• Knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.