Responsibilities
Serve as a highly visible quality professional responsible for interpreting and applying Quality System requirements and developing/maintaining/implementing Standard Operating Procedures (SOPs) and organizational policies within the instrument manufacturing plant
Make key decisions and recommendations that target critical organizational objectives
Support diagnostic instruments throughout the medical device life cycle, including manufacture, distribution, and post market surveillance
Ensure the successful completion of major quality system and business initiatives, including serving as project manager and reporting status to leadership
Provide expert guidance across core Quality System elements, including process control and supplier qualification, while identifying and driving continuous improvement opportunities (both internal and external)
Expert in the use of statistical tools and data analysis techniques to identify trends and root causes, drive corrective actions, and resolve moderately complex quality issues effectively
Support internal and external audit activities, ensuring readiness and compliance
Apply advanced quality engineering principles, technical concepts, and quality science methodologies to deliver measurable and validated results
Provide training and mentorship to other members of the Quality team as well as guidance on Quality Principles, policies, and best practices cross-functionally
Identify issues that may delay products or projects and recommend appropriate actions
Ensure all documentation processes are compliant with applicable regulatory and quality standards
Required Qualifications
Bachelor's degree and 10 years experience in a regulated environment.
Master's degree and 5 years experience in a regulated environment.
5 years of experience in Quality Engineering
Certification in at least one of the following: ASQ-CQA/CQE, AAMI, AOAC, and/or Six Sigma (Green Belt, Black Belt, etc. is preferred.
Knowledge and Skills
Significant track record of root cause determination and effective corrective / preventive action (CAPA) implementation.
Ability and skill to effectively manage multiple tasks and lead the successful and timely execution of projects.
Ability and skill to lead or manage (by influence) the Quality function for engineering projects, reliability concepts for complex systems, validation planning / execution, and continuous improvement projects using statistical sampling, six sigma root cause analysis tools and project management techniques.
Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations.
Skilled at using systematic analysis tools that include Six Sigma, root cause, failure analysis and risk assessment to gather critical information and diagnosis.
Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution.
Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standards (ISO) 13485:2016.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
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?
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
Required Skills
Optional Skills
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- Primary Work Location
- USA MD - Sparks - 7 Loveton Circle
Additional Locations
Work Shift 

 At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
- Salary Range Information
- $117,800.00 - $188,600.00 USD Annual
