Job Information
BD (Becton, Dickinson and Company) Quality Systems Specialist II in Research Triangle Park, North Carolina
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.
This position will function within the Quality Assurance Unit of Corporate Preclinical Development and Toxicology and will participate in the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with GLP regulations and the BD CPDT Quality System.
The Quality Systems Specialist II is accountable for support of the continued development, improvement and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions and problem solving techniques to promote New Product Development and provide support to project teams for process improvement and continuous improvement activities.
Responsibilities
1 Responsible for utilizing and developing phase and systems audit programs for internal laboratory functions and external suppliers in direct support of 21 CFR Part 58, ISO 17025, and the overall Quality System. Quality Assurance Unit documentation/activity support applies to most aspects of the systems employed by BD CPDT for material risk assessments, material characterization, and internal/external GLP biocompatibility testing for medical devices as described in ISO 10993 and FDA G95-1.
2 Active Participation in the development, implementation and maintenance of various aspects of the BD CPDT Quality System including creating and reviewing documents (SOPs, Procedures, Methods, Protocols) in overall support of continual quality improvement.
3 Support the BD CPDT Training System in order to ensure training is performed and documented in order to maintain compliance to Quality System and regulatory requirements.
4 Support the BD CPDT Document Control system for all controlled documents including but not limited to Policies, Protocols, Reports and Standard Operating Procedures.
5 Accompany representatives from sponsoring organizations or government regulatory agencies during site audits.
6 Responsible for GLP, ISO and Quality System training.
7 Responsible for maintaining the Master Schedule.
8 Assist with Metrology program including maintenance of Regulatory Asset Manager System.
9 Assist in management of the supplier audit and approval system, including setting audit dates with suppliers and performing audits.
10 Collaborate with managers, scientists and Quality Assurance personnel to develop process improvements in order to enhance testing and workflow efficiency.
11 Maintain an environment of continuous improvement and quality aligned with BD core values and strategic objectives.
Minimum Requirements:
Bachelor’s Degree in a scientific discipline with two years of relevant experience
Working Knowledge of Quality Systems Regulatory requirements and application to Company/Unit requirements
GLP experience and ASQ certification, preferred
Direct knowledge of the ISO 17025 laboratory certification program, preferred.
Moderate level of application of Quality System Standards to assigned Quality system area.
Demonstrated ability to work successfully independently as well as part of a team.
Excellent verbal and written communication skills.
Must have the ability to focus and to execute multiple projects and programs simultaneously while maintaining attention to detail.
This position requires excellent organizational and the ability to adapt rapidly to changing priorities in a high volume scientific testing laboratory.
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 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 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.
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Primary Work Location
USA NC - Research Triangle Park
Additional Locations
Work Shift
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.