Npi quality manager – responsibilitiescollaborate with npi and operations and engineering departments to develop, conduct and approve validation strategies for products and processes.lead or support quality improvement initiatives—such as the characterization of processes and products—to achieve continuous improvements and cost reduction.review and analyze the effectiveness of pdca, six sigma, kaizen, lean techniques and other improvement programs.perform benchmarking to develop more effective methods to improve quality.establish and formulate quality metrics to maintain quality assurance objectives and align with plant objectives.support the development of quality engineering and compliance for the introduction of new products and product lifecycle management.promote and support the implementation of quality, product and process improvement projects.revise and approve engineering change orders (ecos).evaluate, monitor and analyze quality costs to maintain a quality system according to medical industry standards.review and analyze current products and processes for compliance with regulations such as qsrs, iso 13485, etc.lead preparation activities for regulatory agency audits and act as sme or escort for fda, jjrc, bsi, etc.revise and approve responses to internal and external audit observations to ensure compliance.establish and maintain required documentation of quality assurance activities and supply quality systems.ensure periodic audits of the line to evaluate gmps, production controls, lot segregation and process audit according to jjps.define, monitor and administer the central budget of the department/cost.direct and attend revision meetings of nonconformities (ncs) as a member of the mrb.revise and approve investigations, bounding, documentation, revision and approval of ncs, capas, customer complaints and escalation of quality problems.identify material segregation, classification of defect types, and apply defect analysis techniques in manufacturing.provide direction and assign resources for the resolution of complex manufacturing process problems.revise and approve process validation strategies.ensure periodic maintenance and revision of ctqs in manufacturing processes.approve revision and maintenance of pfmeas, quality control plans, process instructions and other manufacturing documents.support development and implementation of process monitoring and control methods consistent with risk level.promote innovative tools for timely detection and mitigation of risks.responsible for risk assessment evaluation, including fmea documentation for changes in product/process.collaborate with quality leaders to identify required quality engineering skills and competencies.perform strategic planning with site leaders and product engineering team; collaborate with other functions to establish priorities and resource assignments.provide supervision, mentoring, coaching, performance review, development plans and succession planning.ensure subordinates follow all company guidelines related to health, safety, and environmental practices.ensure personal and company compliance with all federal, state, local and company regulations, policies, and procedures.perform other duties assigned as needed.qualifications / requirementsbachelor’s degree in mechanical, electrical, industrial, or applicable sciences.master’s or doctorate in applicable sciences, preferable.8 to 10 years of work experience or demonstrated performance.proficiency with computer packages.ability to effectively deal and negotiate with representatives of governmental and auditing agencies.excellent communication skills in english, spoken and written.ability to actively participate in problem solving and resolution.capacity to solve problems using good judgment.certifications such as cqa, cqe, cqm (preferably), cba, mbb or bb are a plus.required skillscompliance management, corrective and preventive action (capa), cross‑functional collaboration, developing others, fact‑based decision making, giving feedback, good manufacturing practices (gmp), inclusive leadership, iso 9001, leadership, quality control (qc), quality management systems (qms), quality standards, quality validation, risk assessments, standard operating procedure (sop), tactical thinking, team management.
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