Senior Quality Engineer

**"Johnson & Johnson companies are equal opportunity employers"** - At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity._ - Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world._ - When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough._ **COMPANY** **SENIOR QUALITY ENGINEER** **DUTIES AND RESPONSIBILITIES** **Business Improvement** - Revision / analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs. - Performs benchmarking to develop more effective methods to improve quality. - Support the development of quality engineering and compliance of the quality with the adequate abilities for the introduction of new products, and management of the life cycle of the product. - Revises and approves engineering change orders. (ECOs). **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 the preparations activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.). - Responds to internal or external audit observations related to the quality engineering function. - Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems. - Performs periodical audits to the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS. Checks the audit results of the area to ensure that the corrective and preventive actions are adequate. **New products / Process Introduction** - Works with NPI and with the manufacturing, process engineering and manufacturing engineering departments in order to develop, conduct and approve validation. **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 of products and processes. **Product Quality, Control and Disposition and Performance Standards** - Directs and attends to NCs Revisions meetings as a member of MRB. - Conducts and 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 applicable. - Provides support in the analysis of products related to customer complaints, to determine failure modes. - Analyze / check the effectiveness of preventive and corrective actions. - Defines sampling plans and approves inspection methods for evaluation and acceptance of components and finished product. - Provides support in the resolution of complex problems (technically) associated with the manufacturing process to a local or franchise level. **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. - Develops, maintains and checks that the measuring methods are appropriate for the manufacturing processes. - 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 need of risk mitigation techniques given product classification, potential types of defects, defect frequency, severity, risk for the patient, process capacity, process controls, 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 documentation of the risk assessment such as FMEA of the process given the changes in the product/process. **People** - 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. - Responsible for ensuring subordinates follow all Company guidelines related to