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QS Specialist, Calibration

2 months ago

Franklin Lakes, United States BD (Becton, Dickinson and Company) Full time

**Job Description Summary** As directed by the Senior Manager, Quality Systems, the QS Specialist, Calibration & PM Coordinator is accountable for the monitoring, improvement, and implementation of the MDS FLKS Calibration and Preventive Maintenance (PM) program. **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. **Responsibilities:** + Act as the Calibration and Preventative Maintenance (PM) Program Coordinator for the MDS Franklin Lakes Site. + Provide guidance to the asset owners in determining the need for calibration and establishing the calibration parameters (e.g. use range, frequency, tolerance, etc). + Provide guidance to the asset owners in determining the need for preventative maintenance (PM) and establishing PM parameters (e.g. frequency, PM tasks, etc.). + Ensure all assets are recorded and maintained in Blue Mountain Regulatory Asset Manager (BMRAM) data base. + Ensure assets are calibrated and maintained within the established frequency. + Support the asset owners in identifying and documenting out-of-tolerance issues and take appropriate corrective and preventative actions. + Approve all calibration/PM extensions and OOTs. + Ensure that a justification is documented for those equipment/instruments that do not require calibration. + Provide calibration/PM labels to asset owners. + Ensure that calibration and PM systems at MDS Franklin Lakes site comply with corporate, BU, and applicable regulations. + Maintaining calibration and PM files and ensure their compliance with record retention requirements. + Ensure service suppliers (e.g. external calibration services) are approved and managed according to BDX and MDS supplier management program. **Minimum Qualification:** + Bachelor's Degree in Engineering or related discipline. + 2 years relevant industry experience. + Working knowledge of US and International regulations and standards that apply to the medical device industry (FDA QSR, ISO13485, EU MDD/MDR). + Experience with SAP. 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. 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  om/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. PDN **Primary Work Location** USA NJ - Franklin Lakes **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.