Director, Quality Management, EMI Operations, Sustaining and Service at Becton Dickinson NA in Zelienople, Pennsylvania

Job Description:

Job Description Summary




Job Description



We are the makers of possible



BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.


We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.


The Director, Quality Management, EMI (Electromechanical Instrumentation) Operations Sustaining and Service reports to the Vice President of Quality EMI. This role is responsible for developing and maintaining quality assurance programs, policies, procedures, and controls for pre-production supplier qualification, capability development, and manufacturing quality. It ensures product performance and quality meet requirements, standards, and regulations for all BU product platforms at various sites: San Jose, CA; Sparks, MD; San Diego, CA (Dispensing and Pumps); and Durham, NC (Parata Systems).


The Director ensures the business units' quality systems and quality management system meet requirements and standards, including BD corporate quality policies. Plant quality leaders in DS, BDB, MMS, and UCC report directly to the Director and are under their authority for performance reviews, career development, compensation, hiring, and termination. The Director also partners with operational or platform team leaders, operating with independence but under oversight from senior quality and regulatory compliance leaders.


Responsible for overseeing quality design transfer, ensuring the quality team has the skills and resources to meet R&D and innovation objectives. This role manages service depots, sustaining, operational and design transfer quality across various sites and regions, including resource management, recruiting, retention, and succession planning. The Director collaborates with peers to support operations and supplier quality and compliance within each business unit.



Key Responsibilities



This leader will provide input into and support the VP Quality EMI in the development of the overall EMI plant and sustaining quality strategy. This leader will develop quality programs to oversee and foster: process capability, new products supplied component readiness and introduction, product enhancements, material changes, operations quality and supplier quality expert-level leadership and guidance for a dedicated team. This role has responsibility for the EMI product lines' manufacturing and depot repair quality practices. This role serves as the primary liaison between quality and platform leadership. Define and influence a quality culture that enables both rapid transformation of ideas to requirements to products and diligent and deliberate compliance to internal quality management system requirements in design and developing them. Multi-BU authority and accountability for developing, deploying, and maintaining a robust and compliant quality management system for the design, risk management, and ongoing life-cycle maintenance of BD products. Actively identify improvements to the processes within the QMS to enhance both compliance and quality. Provide expert-level understanding of qualification and validation, nonconformance control, process capability, risk reduction, and supplier management requirements and how to deploy them in a large-scale and rapidly evolving business. Provide operations and supplier quality leadership during FDA and notified body site inspections. Interface with the FDA on Post-Market Activities: site inspections, manufacturing complaints, additional information requests. Acquire and develop excellent-level leaders and teams to support the EMI mission and actively manage bench-strength and succession planning. Assess resource needs to align the required level of quality support provided when needed with suitable competencies, including shifting resources between Platforms when appropriate. Maintain effective design-related quality metrics and define and execute activities to improve performance. Actively support and demonstrate the BD values in daily work. Other assignments as directed by the Vice President Quality Management EMI .



Education



Bachelor's degree in a technical field required. Engineering degree strongly preferred. Master's degree in a technical field preferred.



Experiences



Minimum of ten (10) years' experience in the following areas: Electromechanical Instrumentation, Quality Assurance/Control, Statistical analysis, FDA QSR's (21 CFR Part 820), lean manufacturing, risk management (ISO 14971), and ISO/EC (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL) requirements.



Required Knowledge and Skills

• Knowledge and application of ISO 13485, 21 CFR 820 and 21 CFR 210-211, MDD/MDR, IVDD/IVDR, requirements and European/US GMPs related to medical device and pharmaceutical manufacture.


• Experienced in project management.


• Organizational / motivational skills.


• Capable of managing a range of projects and activities in parallel.


• The ability to manage by influence in addition to functional responsibility.


• The preparation, planning and presentation of key initiatives.


• The ability to coordinate effectively across regions.

Why Join Us?



A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve 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. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization's investment in BD University, you will continually level up your tech skills and expertise.


To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers



Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not 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 legally-protected status.


Required Skills


Optional Skills


.

Primary Work Location

USA PA - Zelienople



Additional Locations

USA CA - San Diego Bldg A&B, USA NC - Durham - Roche Drive



Work Shift



At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .


Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.



Salary Range Information

$163,000.00 - $293,300.00 USD Annual Apply Now