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BD (Becton, Dickinson and Company) Sr. Quality Manager - Intelliport Platform in Franklin Lakes, New Jersey

Job Description SummaryReporting to the Director of Quality, the Senior Manager provides direct management and technical support to the Quality Engineers supporting the Intelliport Platform. The role significantly influences the definition of the strategy and determines the tactics required to achieve objectives. Through outstanding communication; effective problem solving and active management of ambiguous situations; Senior Manager ensures product safety, product quality and compliance with all relevant global regulations and customer expectations. Success is measured in terms of the frequency and scale of product quality organizational issues as well as business process effectiveness. Through stakeholder engagement; and people development; the Senior Manager produces durable and industry leading results supporting key business drivers.

Job Description

Primary Responsibilities:

  • Provide leadership and guidance to ensure software quality objectives are met for product software, manufacturing software, quality system software, and software technologies included or used in the creation or production of medical devices.

  • Lead the resolution to software quality challenges and software quality improvement opportunities.

  • Ensures that project documentation including Software Development Plans, Software Requirements Specifications, Software Design Documents, Software Test Plans/Protocols/Reports are complete and meet all Quality System and regulatory requirements.

  • Engage with (or may lead) quality networks as well as the business unit and associates toward the effective promotion and alignment of organizational goals to the company‚Äôs mission and vision.

  • Ensure the plant/functional quality organization is organized and resourced to fulfill its obligations and to comply 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 stakeholder engagement focused on win-win solutions.

  • Continuously evaluate progress toward objectives adapting them to meet customer and business needs

  • Pursue and actively manage key stakeholder relationships that support the broader strategy that are impacted by plant/business/function objectives

  • Manage customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards.

  • Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors.

  • Perceived as thought leader possessing subject matter expert knowledge of global regulation.

  • Contribute to development of local and/or global strategies.

  • Accomplishes tasks through highly experienced professional specialists or manager.

  • Serves as Quality representative on Intelliport Leadership Team

  • Maintain an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies.

Education and Experience Requirements:

  • Typically requires a minimum of a Bachelor's degree in science, engineering or other relevant discipline with a minimum of 6 years with relevant supervision.

  • Demonstrate functional knowledge and expertise software development, software lifecycle (SDLC) processes, regulatory requirements, international standards, and risk management

  • Prior experience with Regulated software development

  • Class II / III medical device experience preferred

  • Strong knowledge of Software Development Lifecycle Processes

  • Understanding of 21CFR820, ISO 13485, IEC-62304, IEC-60601, IEC-62366

  • Understanding of Cyber Security requirements for medical devices

  • Quality Engineering tools, Statistics, Problem Solving, strong Interpersonal Skills, Leadership, all forms of Communication

  • ASQ Certificate(s) desirable (but not required)

  • Design for Six Sigma preferred

  • Knowledge of Agile development process and tools preferred

#LI-PRO

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.

Primary Work LocationUSA NJ - Franklin Lakes

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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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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