Staff Quality Engineer

**Job Function**:Quality**Job Sub Function**:Quality Assurance**Job Category**:Professional**All Job Posting Locations**:Ciudad Juarez, Chihuahua, Mexico**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.** 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.** 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.- 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 manufacturi