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Sr. Manager, Quality Engineering (Hybrid/Office)

Company: Becton Dickinson
Location: Franklin Lakes
Posted on: June 25, 2022

Job Description:

Responsibilities Job Description SummaryThe Senior Manager, Quality Management is responsible for contribution to the definition of the strategy and tactics required to achieve site/business unit/business line objectives for the Specimen Acquisition Business Line (SABL) and Emerging Specimen management (ESM) Business Line. The Senior Manager, Quality Management ensures product safety, product quality, and compliance with all relevant global regulations and customer expectations. 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. PRIMARY DUTIES, RESPONSIBILITIES & AUTHORITIES Engage with (or may lead) global quality networks as well as the business unit, site, business line and associates toward the effective promotion and alignment of organizational goals to the company's mission and vision. Ensure the site/unit/business line organization is designed and resourced to fulfill its obligations and to align with applicable regulations and procedures. Mentor and develop personnel, including dedicated succession planning and contingency management. Effectively navigate and lead through the challenges of change and establish key partner engagement. Continuously evaluate progress toward objectives adapting them to meet customer and business needs. Pursue and actively manage key collaborator relationships that support the broader strategy. Manage customer impacting issues; prioritizing quality and compliance solutions that uphold the company and its standards. Maintain positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors. Contribute to development of local and/or global strategies. Accomplishes tasks through highly qualified professional specialists and/or managers. May act as Management Representative for notified bodies and liaison with regulatory agencies and customers. This can include hosting and managing related audits and ensuring effective resolution of issues/nonconformities. May serve on leadership teams such as the Executive Steering Committee (ESC), Plant Leadership Team (LT), and Extended Quality LT. Maintain an influential and effective network and communication with LT members for identifying quality improvement opportunities to evaluate, propose, and implement new processes and technologies to optimize efficiencies. Prepares/supports budgets and maintains a cost control under their areas of responsibility. This role may have P&L accountability. May perform other duties as required. KNOWLEDGE AND SKILLS Experience and working knowledge of the Lab Specimen Management products is required. Working knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, MDSAP, EU MDR/IVDR) Experience with leadership, communication, organization, and project management skills Knowledge of design controls, risk management, and production & process controls Ability to demonstrate knowledge of quality processes Ability to effectively manage and lead teams and influence professionals Strong interpersonal skills and ability to collaborate with other functions, business units, business lines and external partners Ability to lead and influence without authority Ability to communicate effectively in writing and orally, to organize work, and to achieve results when working alone or in teams. Experience and expertise in data analysis and statistics (SPC, Pareto charts, etc.) Demonstrated ability to support computer systems implementation, including data migration. Certified Quality Auditor, Engineer, Supplier Quality Professional, Quality Manager, or Transactional Six Sigma Green/Black belt desirable. Must have knowledge/specialization in one or more of the following areas: Quality Systems Calibration CAPA Complaints Computer System Validation Continuous Improvement Design Controls Documentation Management Environmental Monitoring EU MDR/IVDR External Auditing Management Field Actions (Corrections and Removals) Internal Audit Label/IFU/Graphics Controls Management Review/Controls Nonconforming Material/Processes Post-Market Surveillance Product Inspections (Incoming, In-Process, Final Release, etc.) Quality Data Analysis Risk Management Sterilization methods and application Supplier Quality Training Validation (software, product, process, etc.) EDUCATION AND EXPERIENCE This position typically requires a minimum of a bachelor's degree in science, engineering, or other relevant discipline with a minimum of six (6) years relevant experience in the pharmaceutical and/or medical device industries, with two (2) years supervisory experience. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. 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 Becton, Dickinson, and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate based on 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.PDN Primary Work LocationUSA NJ - Franklin Lakes Additional Locations Work ShiftUS BD 1st Shift 830am-5pm (United States of America) Apply Save Job PDN-95ea64be-e42d-464c-8cd9-f708ccd2b439

Keywords: Becton Dickinson, New York , Sr. Manager, Quality Engineering (Hybrid/Office), Administration, Clerical , Franklin Lakes, New York

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