STAFF Quality Engineer (segundo Turno)

Staff 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.

Job Function: Quality

Job Sub Function: Quality Assurance

Job Category: Professional

Locations: Ciudad Juarez, Chihuahua, Mexico

Job Description:

The Quality Engineer Staff plans or adapts the new methods or procedures to control or coordinate all the aspects of several projects 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.

You will be responsible for:

· 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).

· 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. Revises the audit results of the area to ensure that the corrective and preventive actions are adequate.

· Controls and maintains the central budget of the department/cost.

· Works with NPI and with the manufacturing, process engineering and manufacturing engineering departments to develop, conduct and approve product and process validation strategies.

· 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.

· Revises, approves, executes IQ, OQ, PQ, TMV or Software Validation.

· Maintains and periodically checks the CTQs in the manufacturing process to guarantee the continuous satisfaction of the customer.

· Develops, maintains and checks that the measuring methods are appropriate for the manufacturing process.

· Provides support in the revision and maintenance of PFMEAs, Quality control plans, process instructions, and additional manufacturing documents.

· Develops, interprets and properly implements process monitoring and control methods consistent with the risk level of the process/product.

· Evaluates and interprets the causes of common vs special variation in the manufacturing process and determines the adequacy of the limits of the current processes.

· Evaluates the need of risk mitigation techniques due to the product classification, potential types of 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 as FMEA of the process due to the changes in the product/process.

· Collaborates with the quality leaders to identify the required quality engineering skills and competences that allow the execution of the strategic vision.

· Provides supervision, mentoring, coaching, performance revision, development plans and planning of the succession for others (when applicable).

Requirements:

Education: As minimum, Bachelor, preferably in engineering: Mechanical, Electrical, industrial or applicable science.

Experience and Skills:

Required:

· 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.

· Strong knowledge of statistical software packages, preferably, with the capacity of previsualizing, create graphs and analyze data and be capable of presenting data that facilitates the taking of decisions.

· Ability to perform an "active involvement" in the solution of problems and resolution of problems, preferably.

· Capacity to solve problems and provide good judgment, highly desirable.

· Demonstrated management abilities of projects and leadership projects, preferably.

· Certifications such as CQA and CQE (preferably), CBA and Green Belt are a plus.