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 https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Quality Assurance **Job Category:** People Leader **All Job Posting Locations:** Ciudad Juarez, Chihuahua, Mexico **Job Description:** 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 We are searching for the best talent for **SENIOR QUALITY OPERATIONS MANAGER​** 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. 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. You may be designated as a Management Representative. **DUTIES & RESPONSIBILITIES** In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: **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, 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. **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. • 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. 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 analysis documentation such as process FMEA given product/process changes. **Strategy** • 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. **People** • Provides supervision, mentoring, coaching, performance review, development plans and succession planning for others (where applicable). o Responsible for communicating business related issues or opportunities to next management level o Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. o 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 o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures o Performs other duties assigned as needed **EXPERIENCE AND EDUCATION** o Minimum Bachelor's degree, preferably in engineering: Mechanical, Electrical, Industrial or applicable science. o Master's or Ph.D. in applicable science is preferred. o 8-10 years of work experience or demonstrated performance. REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS o Computer package management. o Ability to deal effectively and negotiate with representatives of various government agencies and auditing agencies o Excellent communication skills in English both written and oral. o Ability to perform "hands on" problem solving and problem solving is preferred. Ability to problem solve and provide sound judgment is highly desired. o Certification such as CQA, CQE, CQM (preferred), CBA, MBB or BB a plus. _I_ _f you wish to apply, please consider the following information from our Global Job Posting Policy:_ _• We require you to have spent at least 18 months in your current position, and in good standing (not under a Performance Improvement Plan [PIP]). For any exception, you must secure the approval from your current manager and Human Resources Business Partner._ _• As our employee, you may apply for a position without informing the current manager. However, when invited to interview, then, to the extent that this is consistent with local law or practice, you are required to notify your manager prior to the interview. This notification is inspired to promote development discussions between the managers and our employees._ _• If you want to refer external talent for this position, please review our Global Referral Policy and submit your referral through Career Hub by following the appropriate process._ _For more details, please review our Global Job Posting Policy in AskGS._