Job Description Summary # Job Description # Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. The Quality Assurance Manager has the responsibility of managing and developing the QA Team in Irvine, CA. The individual provides Quality Engineering/Systems leadership to support Operations and to drive continuous improvement while ensuring compliance to procedures and requirements. The daily tasks associated with the role are incoming quality control, manufacturing, materials management, labeling, and product disposition management along with maintenance of the quality system. ## Essential duties and responsibilities: + Manages QA department and overall expectations pertaining to setting accurate schedules, costs and resources. + Ensures department is adequately resourced and trained to perform jobs effectively. + Directly supervises QA staff including mentoring and developing to enable maximum performance and individual employee growth, providing regular performance review and feedback and using corrective action as necessary. + Ensures delivery against QA department goals and objectives, i.e. meeting commitments and coordinating overall quality assurance schedule. + Encourages a team environment, leads by example and demonstrates servant leadership skills. + Prepares and maintains department budgets. + Serves as a team member to provide quality engineering expertise to continuous improvement teams and manufacturing support. + Implements ongoing quality improvement processes working with interdepartmental teams. + Develops project schedules and resource allocation models for QA related projects and other activities to support project teams. + Provides effective communication regarding issues, objectives, initiatives and performance to plan. + Develops inspection and process control procedures, processes through document control and provides training for the procedures. + Develops metrics to identify and prioritize activities pertinent to process control, risk reduction, and cost improvement. + Manages non-conformance data and provides oversight for corrections, trending, tracking, external communications, closure and reporting. + Develops, tracks, trends, reports and maintains Quality Indicators to enhance quality of products and business performance. + Facilitates communication and teamwork between R&D/NPD and Operations, towards the purpose of design transfer. + Ensures conformance to change control requirements for process and production changes. + Maintains compliance to FDA Quality System Regulations, ISO:13485 standards and other regulations, as applicable. + Performs special assignments and other duties as assigned. + Interfaces effectively with senior leadership. + Supports internal and external audits/inspections. + Prepares and implements facility policies and procedures relating to quality. + Ensures alignment and compliance to Corporate, Segment, Business Unit, and Department procedures. ## Qualifications: + Verbal communication skills and presentation skills: Ability to create and understands how to present information dependent upon the level of the audience. + Technical writing skills: Creating reports, presentations, rework protocols, validation protocols, metrics, procedures, forms, flowcharts, quality plans, quality agreements, etc., and review and approve technical documentation, as required. + Leadership skills: Prioritizing resources based on changing business needs. + Budgeting skills: Ability to control costs while providing appropriate resources in order to maintain compliance posture while meeting business needs. + Computer skills: Ability to create and manage technical documents, as needed; ability to use electronic communication, time management, ERP and EDMS systems. + Knowledge of medical device regulation, industry or international standards. Ability to understand Organization, Corporate, Business Unit, and other Facilities Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. + Knowledge and demonstrated use of document control, training and time management practices and investigational techniques (e.g., CAPA, non-conformance, thresholds, fishbone, 5-Whys). + Ability to interpret Regulations and Procedures. + Extensive knowledge of quality systems and relationship to business, along with inspection, testing, product release, manufacturing processes and associated systems. + Fundamental knowledge of validation principles. + Understands basic applied statistics, statistical sampling plans, and statistical process control.. + Ability to find opportunities for quality and cost improvements. + Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understand team functions, leadership techniques and project management methodologies. + Ability to effectively manage time and handle multiple task assignments. + Ability to translate quality requirements into product specifications. ## ## EDUCATION and/or EXPERIENCE: + Bachelor’s degree or higher in Science, Engineering, Technology or related field. + Minimum of seven (7) years’ experience in quality engineering within medical device or pharmaceutical manufacturing. + Two (2) plus years' supervisory experience. + Thorough knowledge of regulations governing production, packaging, inspection (preferably incoming/final release), testing and warehousing. + ASQ CQE certification preferred. # Why join us? A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates. ## To learn more about BD visit https://jobs.bd.com/ Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. #LI-PRO # Primary Work LocationUSA CA - Irvine Neomend # Additional Locations # Work Shift Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.