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Senior Quality Engineer
role at
BD
As directed by the Quality Manager, the Senior Quality Engineer will be a member of the Advanced Access Devices (AAD) platform and will be accountable for product maintenance and new product development through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and will play an active role in processes to ensure products meet quality standards consistent with both Corporate and unit policies while meeting all design control and regulatory requirements.
Responsibilities
Provide guidance and quality oversight for robust design control programs aligned with regulatory requirements and industry standards.
Support new product development and existing product sustaining activities, ensuring work follows proper design control and meets BD and FDA regulatory requirements.
Ensure adequate design control documentation and records are maintained to support the complete lifecycle of design history.
Support execution of design control activities including project planning, design inputs, critical-to-quality characteristics, risk analysis, design reviews, validations, verifications, and design history files.
Provide guidance and training to associates across departments to increase knowledge of regulations and standards.
Evaluate design verification results and data using statistical analysis to ensure designs deliver acceptable quality levels during manufacturing with properly established product specifications.
Ensure designs are appropriately specified and established before transferring into manufacturing to mitigate risks.
Review and authorize quality approval for new product and device design specifications, including performance specifications, test methods, acceptance criteria, and release.
Review work performed by R&D and other business units to ensure quality issues are adequately addressed with appropriate corrective actions.
Work with the Validation team to provide Quality Engineering support for product/device transfer, scale-up, and process validation.
Lead or participate in ISO 14971 Risk Management activities appropriate to initiatives or situations.
Monitor quality data from various sources to identify, investigate, troubleshoot, and resolve quality issues.
Initiate Corrective and Preventative Action plans and perform efficacy follow-up.
Conduct supplier evaluations and establish required controls to meet BD and regulatory requirements.
Participate in supplier capability and internal audits to evaluate effectiveness of GMPs and established Quality Systems.
Assist Regulatory Affairs by providing input for submissions or responses to agency queries and support regulatory inspections.
Lead investigations and field activities relating to Field Corrective Actions when needed.
Qualifications
Bachelor’s degree in STEM and six (6) years of engineering experience OR Master’s degree in STEM and four (4) years of engineering experience required. Design Controls, Risk Management and Change Controls is required.
Experience in medical device industry is required.
American Society of Quality (ASQ) certification (CQE, CQA, etc) preferred.
Why Join Us? BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our purpose, and 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. Join us to discover an environment in which you’ll be supported to learn, grow, and become your best self.
Workplace Requirements In most BD roles, a minimum of 4 days of on‑site presence per week is required. Remote or field‑based positions will have different workplace arrangements indicated in the job posting. For certain roles, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID‑19. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Equal Opportunity Employer 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.
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Senior Quality Engineer
role at
BD
As directed by the Quality Manager, the Senior Quality Engineer will be a member of the Advanced Access Devices (AAD) platform and will be accountable for product maintenance and new product development through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and will play an active role in processes to ensure products meet quality standards consistent with both Corporate and unit policies while meeting all design control and regulatory requirements.
Responsibilities
Provide guidance and quality oversight for robust design control programs aligned with regulatory requirements and industry standards.
Support new product development and existing product sustaining activities, ensuring work follows proper design control and meets BD and FDA regulatory requirements.
Ensure adequate design control documentation and records are maintained to support the complete lifecycle of design history.
Support execution of design control activities including project planning, design inputs, critical-to-quality characteristics, risk analysis, design reviews, validations, verifications, and design history files.
Provide guidance and training to associates across departments to increase knowledge of regulations and standards.
Evaluate design verification results and data using statistical analysis to ensure designs deliver acceptable quality levels during manufacturing with properly established product specifications.
Ensure designs are appropriately specified and established before transferring into manufacturing to mitigate risks.
Review and authorize quality approval for new product and device design specifications, including performance specifications, test methods, acceptance criteria, and release.
Review work performed by R&D and other business units to ensure quality issues are adequately addressed with appropriate corrective actions.
Work with the Validation team to provide Quality Engineering support for product/device transfer, scale-up, and process validation.
Lead or participate in ISO 14971 Risk Management activities appropriate to initiatives or situations.
Monitor quality data from various sources to identify, investigate, troubleshoot, and resolve quality issues.
Initiate Corrective and Preventative Action plans and perform efficacy follow-up.
Conduct supplier evaluations and establish required controls to meet BD and regulatory requirements.
Participate in supplier capability and internal audits to evaluate effectiveness of GMPs and established Quality Systems.
Assist Regulatory Affairs by providing input for submissions or responses to agency queries and support regulatory inspections.
Lead investigations and field activities relating to Field Corrective Actions when needed.
Qualifications
Bachelor’s degree in STEM and six (6) years of engineering experience OR Master’s degree in STEM and four (4) years of engineering experience required. Design Controls, Risk Management and Change Controls is required.
Experience in medical device industry is required.
American Society of Quality (ASQ) certification (CQE, CQA, etc) preferred.
Why Join Us? BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our purpose, and 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. Join us to discover an environment in which you’ll be supported to learn, grow, and become your best self.
Workplace Requirements In most BD roles, a minimum of 4 days of on‑site presence per week is required. Remote or field‑based positions will have different workplace arrangements indicated in the job posting. For certain roles, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID‑19. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Equal Opportunity Employer 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.
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