Site Quality Lead

Diversity, Equity & 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 Move Could Mean Our Next Breakthrough. We are searching for the best talent for SITE QUALITY LEAD to be in Juarez plant Salvarcar. JOB SUMMARY* Plans, coordinates and directs quality assurance programs designed to ensure the continuous production of products consistent with established standards through the following responsibilities, either personally or through subordinates. At this level, the position has a major impact on business results and typically, management responsibility for the group of professionals under his/her charge. If CSS position: This position will have responsibilities across the ETHICON and Cardiovascular and Specialty Solutions (CSS) Family of Companies of Johnson and Johnson) companies including a range of multiple product platforms such as General Surgical Devices, Sutures, ENT, Infection Prevention, Electrophysiology and Surgical and Non-Surgical Aesthetics. If you are a Cerenovus Juarez position: You may be designated as a Management Representative. SECTION 2: DUTIES & RESPONSIBILITIES* Under general direction and in accordance with all federal, state, and local laws/regulations and Johnson & Johnson Corporate procedures and guidelines, this position will Business Improvement - Leads or supports quality improvement initiatives such as process and product characterizations leading to continuous improvement / cost. - Reviews / analyzes the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other improvement tools and programs. - Conducts benchmarking to develop more effective methods to improve quality. - Establishes and formulates quality metrics to maintain quality assurance objectives and alignment with plant objectives. - Supports the development of quality engineering and quality compliance with appropriate skills for new product introduction, and product life cycle management. - Promotes and supports the implementation of quality, product and process improvement projects. - Reviews and approves engineering change orders (ECOs). - Evaluates, monitors and analyzes quality costs to maintain a quality system in accordance with medical industry standards. Compliance / Regulatory - Reviews / analyzes whether current products and processes (including actions or decisions taken) comply with standards, such as QSRs, ISO 13485, EUMDR, etc. - Leads preparation activities for regulatory agency audits, including active participation as "SME" or "Escort" (e.g. FDA, JJRC, BSI, EUMDR etc). - Reviews and approves responses to internal or external audit observations to ensure compliance with internal procedures and applicable regulations. - Establishes and properly maintains required documentation of quality assurance activities and/or quality systems. - Ensures periodic line audits are conducted to evaluate GMPs, production controls, batch segregation and process audits in accordance with JJPS. Reviews results of area audits to ensure corrective and preventive actions are appropriate. Finance - Defines, monitors and manages the department's central budget/cost. New Product / Process Introduction - Collaborates with NPI and the operations and engineering departments to develop, conduct and approve product and process validation strategies. Product Quality, Control & Disposal and Performance Standards - Leads and attends NC Review meetings as a member of MRB. - Reviews and approves investigations, bounding, documentation, review and approval of non-conformances (NCs), corrective and preventive actions (CAPAs), customer complaints and Escalation of quality issues as applicable. - Gives direction and allocates resources for the resolution of complex (technically) problems associated with the manufacturing process at a local or franchise level. Product / Process Qualification - Reviews and approves process validation strategies. - Ensures that periodic maintenance and review of CTQs is performed on the manufacturing process to ensure continued customer satisfaction. - Approves the review and maintenance of PFMEAs, Quality Control Plans, Process Instructions, and additional manufacturing documents. - Supports in the development and proper implementation of process monitoring and control methods consistent with the risk level of the process/product. - Promotes the use of innovative tools for timely risk detection and mitigation. Determines the effectiveness of these techniques on previously implemented improvements. - Responsible for and owns the risk assessment process including the conduct, documentation, review or maintenance of current risk and hazard ana