BD
Overview
BD is seeking a Quality Assurance Engineer II to join our team. In this role, you will play a crucial part in ensuring the quality and compliance of our products and processes. You will collaborate with cross-functional teams to review, approve, and close work orders, support calibration and maintenance activities, and perform equipment and process validation studies. Your expertise and attention to detail will contribute to our mission of advancing the world of health.
Responsibilities
Review, approve, and close all work orders by working with the Metrology and Instrumentation Department to comply with site calibration and maintenance SOPs.
Provide strong proficiency in using Calibration, Maintenance, and Out Of Tolerance (OOT) management systems like BMRAM or equivalent laboratory equipment management systems.
Support the facilities/Calibration department with daily, weekly, and monthly work orders.
Generate and review OOT records, assess their impact, document risk assessments, and ensure timely closure to meet site and company quality metrics.
Monitor monthly workload for department assignments to ensure compliance with established service level agreements.
Generate monthly quality equipment calibration and maintenance data to support the site’s Quality Management System (QMS).
Review and approve completed records within the Life Cycle System maintenance database.
Support site and department daily activities as a quality approver and coordinator.
Review and support Internal and External audits for all calibration, maintenance, and OOT records to comply with ISO 13485, ISO 9001, and FDA regulations.
Provide input to the Calibration and Equipment Maintenance Manager on developing and implementing a comprehensive quality calibration program, including instrumentation budget, adherence to department metrics, equipment service-related contracts, and equipment reliability and regulatory compliance.
Support routine monitoring of the Equipment Life Cycle Management Program and provide input to the daily activities for the Instrumentation team.
Develop a coordinated support strategy to support the business and balance competing priorities.
Perform equipment and process validation studies, including writing, executing, and/or reviewing protocols, reports, data analysis, and deviations for new, existing, and site relocation activities.
Author and execute Installation, Operational, and Performance qualifications for analytical and manufacturing equipment.
Support facility and controlled non-classified environmental manufacturing area validation and qualification of GMP equipment and functions throughout the facility.
Review and update FMEA or Risk documents as needed for validation activities for the site.
Perform additional duties to ensure business continuity and support site and business needs.
Education/Experience Bachelor’s degree in a relevant field such as Engineering, Science, or Quality Assurance. Minimum 2 years experience with validations, calibrations and supplier management in medical device industry.
Certifications
Certified Quality Engineer (CQE) or equivalent certification is preferred.
Knowledge of ISO 13485, ISO 9001, and FDA regulations is highly desirable.
Additional Information At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving. 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. BD may require proof of full vaccination against COVID-19 where permitted by applicable law, and testing may be available or required in some locations. 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. We help each other be great, we hold each other accountable, and we learn and improve every day. BD 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.
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Responsibilities
Review, approve, and close all work orders by working with the Metrology and Instrumentation Department to comply with site calibration and maintenance SOPs.
Provide strong proficiency in using Calibration, Maintenance, and Out Of Tolerance (OOT) management systems like BMRAM or equivalent laboratory equipment management systems.
Support the facilities/Calibration department with daily, weekly, and monthly work orders.
Generate and review OOT records, assess their impact, document risk assessments, and ensure timely closure to meet site and company quality metrics.
Monitor monthly workload for department assignments to ensure compliance with established service level agreements.
Generate monthly quality equipment calibration and maintenance data to support the site’s Quality Management System (QMS).
Review and approve completed records within the Life Cycle System maintenance database.
Support site and department daily activities as a quality approver and coordinator.
Review and support Internal and External audits for all calibration, maintenance, and OOT records to comply with ISO 13485, ISO 9001, and FDA regulations.
Provide input to the Calibration and Equipment Maintenance Manager on developing and implementing a comprehensive quality calibration program, including instrumentation budget, adherence to department metrics, equipment service-related contracts, and equipment reliability and regulatory compliance.
Support routine monitoring of the Equipment Life Cycle Management Program and provide input to the daily activities for the Instrumentation team.
Develop a coordinated support strategy to support the business and balance competing priorities.
Perform equipment and process validation studies, including writing, executing, and/or reviewing protocols, reports, data analysis, and deviations for new, existing, and site relocation activities.
Author and execute Installation, Operational, and Performance qualifications for analytical and manufacturing equipment.
Support facility and controlled non-classified environmental manufacturing area validation and qualification of GMP equipment and functions throughout the facility.
Review and update FMEA or Risk documents as needed for validation activities for the site.
Perform additional duties to ensure business continuity and support site and business needs.
Education/Experience Bachelor’s degree in a relevant field such as Engineering, Science, or Quality Assurance. Minimum 2 years experience with validations, calibrations and supplier management in medical device industry.
Certifications
Certified Quality Engineer (CQE) or equivalent certification is preferred.
Knowledge of ISO 13485, ISO 9001, and FDA regulations is highly desirable.
Additional Information At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving. 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. BD may require proof of full vaccination against COVID-19 where permitted by applicable law, and testing may be available or required in some locations. 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. We help each other be great, we hold each other accountable, and we learn and improve every day. BD 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.
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