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. Learn more at

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

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

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at

We are searching for the best talent for Staff Quality Engineer to be in Cd. Juarez, Chih. at Plant Salvarcar
Purpose
The Quality Engineer I 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 I 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.

You Will Be Responsible For
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

Business Improvement

• 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.

Compliance / Regulatory
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.

Finances

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

New Products / Process Introduction

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

Strategy

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

People
Provides supervision, mentoring, coaching, performance revision, development plans and planning of the succession 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

Performs other duties assigned as needed

Qualifications / Requirements

• As minimum, Bachelor, preferably in engineering: Mechanical, Electrical, industrial or applicable science.
• 6 to 8 years of work experience or demonstrated performance.
• 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 pre-visualizing, 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.

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)