Staff Quality Systems 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 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, Chihuahua, 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.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Staff Quality Engineer, to be in Salvarcar Plant, Juarez, Chih.

JOB SUMMARY

The Quality Engineer Staff plans or adapts the new methods or procedures to control or coordinate all the aspects of several project at the same time and in the solution of the related and technical projects. The engineer Staff is an emergent authority in a specific technical field, exercising a considerable freedom in the determination of the technical objectives of the assignments. In general, it is expected that his/her work result in the development of new or improved methods to reduce risks, equipment, materials, processes, products, and technical methods. The Engineer Staff acts as a mentor for lower hierarchy personnel and provides advice to upper management about technical matters.

The Quality Engineer Staff will use tools and quality engineering practices for the effective and efficient development of transfers and maintenance of products / processes in the whole life cycle of the product. The holder of the position will also use the quality engineering principles and investigation skills for the resolution of complex problems (technically) associated to the manufacturing process at a local or franchise level, including those related to Escalations. He/she will use the appropriate risk management

to prevent the unforeseen failure modes and improve the capacity of the processes. This person will provide support to the business process and supervisor or direct technicians.

EXPERIENCE AND EDUCATION

• As minimum, Bachelor, preferably in engineering: Mechanical, Electrical, industrial or applicable science.
• 6 to 8 years of work experience or demonstrated performance
• Data Analysis
• Problem Solving
• Use of computer packages.
• Ability to communicate in English, orally and written.
• Knowledge of product / process Risk Management (FDA and ISO regulations), preferably.
• Advanced technical training and experience in the use of Statistics and Lean methodologies and Six Sigma, including Measuring System Analysis, SPC, DOEs, reliability, etc.

DUTIES & RESPONSIBILITIES

• Revision / analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other improvement tools and programs.
• Performs benchmarking to develop more effective methods to improve quality.
• Establishes the metrics that are the quality indicators.
• Provides support to the development of quality engineering and the compliance of the quality with the adequate abilities for the introduction of new products, and the management of the life cycle of the product.
• Revises and approves the engineering change orders. (ECOs).
• Establishes the categories of the quality costs and bases of the quality cost
• Revises / analyzes if the current products and processes (including actions or decisions performed) comply with the regulations, such as the 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.
• Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems.
• Performs periodical audits in the line to evaluate GMPs, production controls, lot segregation and audits to the process according to JJPS.

Product Quality, Control and Disposition and Performance Standards

• Directs and attends to Revision meetings of NCs as member of the MRB.
• Conducts or supports the investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs), customer complaints and Escalation of quality problems when applicable.
• Responsible and owner of the identification of material, material segregation, classification of the type of defects, including the successful application of these techniques in the day-to-day in manufacturing.
• Analyzes/revises the effectiveness of the preventive and corrective actions.
• Defines sampling plans and approves inspection methods for evaluation and acceptance of components and finished product.
• Provides support for the resolution of complex problems (technically) associated to the manufacturing process at a local or franchise level.

Product Grading / Process

• Revises, approves, executes IQ, OQ, PQ, TMV or Software Validation.
• Maintains and periodically checks the CTQs in the manufacturing process to guarantee thecontinuous satisfaction of the customer.
• Develops, maintains, and checks that the measuring methods are appropriate for themanufacturing process.
• Provides support in the revision and maintenance of PFMEAs, Quality control plans, processinstructions, and additional manufacturing documents.
• Develops, interprets, and properly implements process monitoring and control methodsconsistent with the risk level of the process/product.
• Evaluates and interprets the causes of common vs special variation in the manufacturing processand determines the adequacy of the limits of the current processes.
• Evaluates the need of risk mitigation techniques due to the product classification, potential typesof defects, defect frequency, severity, patient risk, process capacity, process controls, etc.
• Determines the effectiveness of these techniques in the improvements previously implemented.
• Responsible and owner of the risk assessment process including the realization, documentation,revision or maintenance of the current risk and documentation of the risk assessment such asFMEA of the process due to the changes in the product/process.

 

 

Required Skills:

 

 

Preferred Skills:

Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)