Quality System Specialist, Digital Quality - Solution Delivery & Integration
Becton Dickinson NA
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Benefits offered by this job
Job summary
BD is seeking a Quality Systems Specialist to support the design, validation, and maintenance of our quality management system in a regulated environment. The role involves collaborating with cross-functional teams to ensure compliance and drive system improvements within our US operations.
Responsibilities include end-user support, data analysis, training development, and contributing to dashboard metrics.
Qualifications
- Bachelor's degree in Quality Management, Engineering, Life Science or Technology.
- Minimum of 3 years of experience in quality management systems within a regulated industry.
- Experience with quality management software and tools.
Responsibilities
- Support end users with process and system usage related questions; this includes partnering with TDS and/or vendor on issue resolutions and communication with end users.
- Provide on-demand user support and troubleshoot data/system issues.
- Collaborate with Global Process Owners (GPO) to collect, interpret, and analyze business requirements to shape the design of the quality management system.
- Identify opportunities for system improvements and lead initiatives to enhance system efficiency, user experience, and overall quality management capabilities.
- Shape project direction and timeline and make recommendations that include alternative solutions.
- Support validation and testing activities; this includes authoring PQ test scripts and support execution in alignment with validation protocols.
- Ensure the system is compliant with applicable regulatory agency requirements and company policies.
- Work closely with cross-functional teams to ensure the system meets business needs and compliance requirements.
- Develop and deliver training programs to ensure employees are knowledgeable about quality systems, procedures, and best practices.
- Support dashboard metrics development, ad hoc data extraction, and data analysis.
Skills
Education
Tools
Job description
We are the people who give possibilities purposeBD 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.
- Support end users with process and system usage related questions; this includes partnering with TDS (Technology & Digital Services) and or vendor on issue resolutions and communication with end users.
- Provide on-demand user support and troubleshoot data/system issues.
- Collaborate with Global Process Owners (GPO) to collect, interpret, and analyze business requirements to shape the design of the quality management system.
- Identify opportunities for system improvements and lead initiatives to enhance system efficiency, user experience, and overall quality management capabilities.
- Shape project direction and timeline and make recommendations that include alternative solutions.
- Support validation and testing activities; this includes authoring PQ test scripts and support execution in alignment with validation protocols.
- Ensure the system is compliant with applicable regulatory agency requirements and company policies.
- Work closely with cross-functional teams to ensure the system meets business needs and compliance requirements.
- Develop and deliver training programs to ensure employees are knowledgeable about quality systems, procedures, and best practices.
- Support dashboard metrics development, ad hoc data extraction, and data analysis.
Bachelor's degree, preferably in Quality Management, Engineering, Life Science or Technology field. Minimum of 3 years of experience in quality management systems within a regulated industry (e.g., medical devices, pharmaceuticals).
Excellent analytical, problem-solving, and project management skills. Strong attention to detail and ability to manage multiple priorities. Exceptional written and verbal communication skills with the ability to lead and influence cross-functional teams. Proficient in quality management software and tools, as well as Microsoft Office Suite. Effective meeting and presentation skills. Candidate must be self-motivated, self-directed, a team player, and willing to learn & adapt.
MasterControl, Pega, TrackWise, Power BI, AI, Document Management, Product Holds, Change Control, Complaint Management, CAPA, Field Actions, Audit Programs.
Willing to travel when required. Work in the office at a BD site. At BD, we are committed to supporting our associates' well-being, development, and success through a performance-based culture.
- Annual Bonus
- Potential Discretionary LTI Bonus
- Potential reimbursement of phone useHealth and Well-being Benefits
- Anxiety management program
- Wellness incentives
- Sleep improvement program
- Diabetes management program
- Virtual physical therapy
- Emotional/mental health support programs
- Weight management programs
- Gastrointestinal health program
- Substance use management program
- Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
- BD 401(k) Plan
- BD Deferred Compensation and Restoration Plan
- 529 College Savings Plan
- Financial counseling
- Baxter Credit Union (BCU)
- Daily Pay
- College financial aid and application guidance
- Paid time off (PTO), including all required State leaves
- Educational assistance/tuition reimbursement
- MetLife Legal Plan
- Group auto and home insurance
- Pet insurance
- Commuter benefits
- Discounts on products and services
- Academic Achievement Scholarship
- Service Recognition Awards
- Employer matching donation
- Workplace accommodations
- Adoption assistance
- Backup day care and eldercare
- Support for neurodivergent adults, children, and caregivers
- Caregiving assistance for elderly and special needs individuals
- Employee Assistance Program (EAP)
- Paid Parental Leave
- Support for fertility, birthing, postpartum, and age-related hormonal changes
- Bereavement leaves
- Military leave
- Personal leave
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave
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.
Primary Work LocationUSA NJ - Franklin LakesAdditional LocationsWork ShiftNA (United States of America)
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 $87,200.00 - $139,500.00 USD Annual
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