.**"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
