Quality Engineer I

Johnson & Johnson MedTech; Ciudad Juárez; Presencial; MXN 279.000 - 469.000; Jornada completa

Descripción de la vacante

Johnson & Johnson MedTech is seeking a Quality Engineer II for our Horizontes Plant in Ciudad Juarez, Mexico. The role focuses on applying quality engineering tools across the product lifecycle to improve transfers and maintain processes.

The ideal candidate will have a engineering degree and up to 2 years of experience, with strong problem-solving skills, proficiency in English, and familiarity with GMP, QSRs and ISO 13485 standards.

Formación

• Bachelor’s in engineering: Mechanical, Electrical, Industrial or applicable science.
• 0 to 2 years of work experience or demonstrated performance.
• Statistics knowledge.
• Use of computer packages.
• Ability to communicate in English, orally and in writing.
• Knowledge of engineering fundaments.
• Knowledge of the Product Risk Management / process (FDA and ISO regulations) is preferable.
• Active involvement in problem solving and resolution, highly desired.
• CQA certification (preferably).

Responsabilidades

• Revision / analysis of the effectiveness of PCDA, Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs.
• Revises / analyzes if current products and processes comply with regulations (QSRs, ISO 13485) and supports audits.
• Interacts with regulatory agencies (FDA, JJRC, BSI).
• Responds to audit observations related to quality engineering.
• Maintains documentation of quality assurance activities and systems.
• Performs periodic audits of the line for GMPs and process controls.
• Supports investigations and CAPAs related to non-conformities and customer complaints.
• Analyzes product-related customer complaints to determine failure modes.

Conocimientos

Statistics knowledge

English communication

Quality mindset

Problem solving

Active involvement in problem solving

Educación

Bachelor’s in engineering

Herramientas

QMS

Descripción del empleo

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

Professional

All Job Posting Locations

Ciudad Juarez, Mexico

Job Description

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

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

Purpose

The Associate Engineer plans, provides support to engineering projects or studies. Applies engineering principles and practices within the assigned areas. Can coordinate and direct personnel activities of technical support and is responsible for the technical development of the personnel assigned. The quality engineer associate will use quality engineering tools and practices for the effective and efficient development of transfers and product / processes maintenance in the complete life cycle of the product. The holder of this position will also use his/her abilities of investigation and problem resolution to improve and maintain the products / processes that are aligned with the quality and global business vision. He/she will use the appropriate risk management to prevent unanticipated failure modes and to improve the quality of the processes. This person will provide support to the business processes.

Qualifications / Requirements

• Bachelor’s in engineering: Mechanical, Electrical, Industrial or applicable science.
• 0 to 2 years of work experience or demonstrated performance.
• Statistics knowledge
• Use of computer packages.
• Ability to communicate in English, orally and in writing.
• Knowledge of engineering fundaments.
• Knowledge of the Product Risk Management / process (FDA and ISO regulations) is preferable.
• Ability to perform “active involvement” in the solution of problems and resolution problems, preferable. Capacity to solve problems by providing good judgment, highly desired.
• CQA certification (preferably.

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines.

You Will Be Responsible For

• Revision / analysis of the effectiveness of PCDA, Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs. Compliance / Regulatory
• Revises / analyzes if the current products and processes (including taken actions or decisions) comply with the regulations, such as QSRs, ISO 13485, etc. including providing support during internal and external audits.
• Participates in preparation activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.).
• Responds to internal or external audit observations related to the function of quality engineering.
• Establishes and properly maintains the required documentation of quality assurance activities and/or quality systems
• Performs periodical audits of the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS.
• Checks the audits results of the area ton ensure that the corrective and preventive actions are adequate. Product quality, Control and Disposition and Performance Standards
• Conducts or supports investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs) and customer complaints. Escalation of quality problems when applies.
• Supports the analysis of the products related to customer complaints, to determine failure modes.
• Responsible and owner of the identification of material, material segregation, classification of the types of defects, including the successful application of these techniques in the day-to-day in manufacturing.
• Analyzes / revises the effectiveness of preventive and corrective actions. Product Grading / Process
• Revises, approves, executes IQ, OQ, PQ, TMV or Software Validation.
• Maintains and periodically revises the CTQs in the manufacturing process to guarantee the continuous satisfaction of the customer.
• Provides support in the revision and maintenance of PEMEAs, Quality control plans, process instructions and additional manufacturing documents.
• Develops, interprets and properly implements process monitoring and control methods consistent with the process/product risk level.
• Evaluates and interprets common variation causes vs special in the manufacturing process and determine the adequacy of the current process limits.
• Evaluates the needs of risk mitigation techniques given the classification of the product, potential types of defects, defect frequency, severity, risk to the patient, process capacity, process control, etc.
• Determines the effectiveness of these techniques in the previously implemented improvements.
• Responsible and owner of the risk assessment process including the realization, documentation, revision or maintenance of the current risk and risk analysis documentation such as FMEA of the process given the changes in the product/process. Strategic
• Collaborates with other quality leaders to identify the quality engineering abilities required and competences to allow the execution of the strategic vision.
• Provides supervision, mentoring, coaching, performance revision, development plans and succession planning for others (when applies).
• Responsible for communicating business related issues or opportunities to next management level
• For those who supervise or manage a staff, responsible for ensuring that 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, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures o Performs other duties assigned as needed