SENIOR NPI QUALITY OPERATIONS MANAGER

Johnson & Johnson Innovative Medicine•San Angelo, TX

5d•Onsite

About The Position

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 https://www.jnj.com/medtech 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 surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): MEXICO - Requisition Number: R-071225 USA - Requisition Number: R-073959 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. We are searching for the best talent for SENIOR NPI QUALITY MANAGER for Horizontes Site, Ciudad Juarez. Purpose: 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.

Requirements

Minimum Bachelor's degree, preferably in engineering: Mechanical, Electrical, Industrial or applicable science.
8-10 years of work experience or demonstrated performance.
Computer package management.
Ability to deal effectively and negotiate with representatives of various government agencies and auditing agencies
Excellent communication skills in English both written and oral.
Ability to perform "hands on" problem solving and problem solving is preferred.
Ability to problem solve and provide sound judgment is highly desired.

Nice To Haves

Master's or Ph.D. in applicable science is preferred.
Certification such as CQA, CQE, CQM (preferred), CBA, MBB or BB a plus

Responsibilities

Collaborates with NPI and with the operations and engineering departments to develop, conduct and approve validation strategies of products and processes.
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.
Reviews / analyzes whether current products and processes (including actions or decisions taken) comply with standards, such as QSRs, ISO 13485, etc.
Leads preparation activities for regulatory agency audits, including active participation as "SME" or "Escort" (e.g. FDA, JJRC, BSI, 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.
Defines, monitors and manages the department's central budget/cost.
Collaborates with NPI and the operations and engineering departments to develop, conduct and approve product and process validation strategies.
Leads and attends NC Review meetings as a member of MRB.
Reviews and approves investigations, bounding, documentation, review and approval of nonconformances (NCs), corrective and preventive actions (CAPAs), customer complaints and Escalation of quality issues as applicable.
Responsible and owner of material identification, material segregation, classification of defect types, including the successful application of these techniques in day to day manufacturing.
Gives direction and allocates resources for the resolution of complex (technically) problems associated with the manufacturing process at a local or franchise level.
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 analysis documentation such as process FMEA given product/process changes.
Collaborates with other quality leaders to identify required quality engineering skills and competencies to enable execution of the strategic vision.
Conducts strategic planning with site leaders and product engineering team. Team with other functions to establish business priorities and resource allocation.
Provides supervision, mentoring, coaching, performance review, development plans and succession planning for others (where applicable).
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
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