BD Nogales Norte
Staff Quality Engineer I - Risk Management
BD Nogales Norte, Franklin Lakes, New Jersey, us, 07417
Staff Quality Engineer I - Risk Management
Join to apply for the
Staff Quality Engineer I - Risk Management
role at
BD Nogales Norte
Job Description Summary 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.
Job Summary The Staff Quality Engineer I is accountable for supporting the ongoing maintenance and improvement of product risk files for medical devices. This role is responsible for conducting periodic reviews, assessing the impact of product changes on risk documentation, and ensuring compliance with applicable regulatory requirements.
Key Responsibilities
Lead and execute periodic reviews of risk management files to ensure accuracy, completeness, and regulatory compliance.
Evaluate and update risk documentation in response to product design changes, manufacturing updates, or post‑market feedback.
Provide risk management support for new product development, including initial hazard analysis, risk file creation, and integration with design control processes.
Collaborate cross‑functionally with R&D, Regulatory Affairs, Medical Affairs and Marketing teams to ensure risk files reflect current product status and intended use.
Maintain alignment with ISO 14971 risk management principles and ensure documentation meets IVDR/MDR expectations.
Support internal and external audits by providing risk file documentation and responding to auditor inquiries.
Track and manage risk file updates using document control systems and ensure timely approvals.
Participate in risk‑related training and continuous improvement initiatives.
Required Qualifications
Bachelor’s degree in science, engineering, or other relevant discipline and 8 years relevant experience, OR
Master’s degree in science, engineering, or other relevant discipline and 5 years relevant experience.
Skills
Extensive knowledge of FDA medical device quality system regulations and international quality system standards/regulations (e.g., 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products.
Experience with risk management tools such as FMEA, Fault Tree Analysis, or Hazard Analysis.
Excellent written and verbal communication skills.
Detail‑oriented with strong organizational and analytical skills.
Location USA NJ - Franklin Lakes
Salary Range $130,400.00 - $215,200.00 USD Annual
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.
#J-18808-Ljbffr
Staff Quality Engineer I - Risk Management
role at
BD Nogales Norte
Job Description Summary 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.
Job Summary The Staff Quality Engineer I is accountable for supporting the ongoing maintenance and improvement of product risk files for medical devices. This role is responsible for conducting periodic reviews, assessing the impact of product changes on risk documentation, and ensuring compliance with applicable regulatory requirements.
Key Responsibilities
Lead and execute periodic reviews of risk management files to ensure accuracy, completeness, and regulatory compliance.
Evaluate and update risk documentation in response to product design changes, manufacturing updates, or post‑market feedback.
Provide risk management support for new product development, including initial hazard analysis, risk file creation, and integration with design control processes.
Collaborate cross‑functionally with R&D, Regulatory Affairs, Medical Affairs and Marketing teams to ensure risk files reflect current product status and intended use.
Maintain alignment with ISO 14971 risk management principles and ensure documentation meets IVDR/MDR expectations.
Support internal and external audits by providing risk file documentation and responding to auditor inquiries.
Track and manage risk file updates using document control systems and ensure timely approvals.
Participate in risk‑related training and continuous improvement initiatives.
Required Qualifications
Bachelor’s degree in science, engineering, or other relevant discipline and 8 years relevant experience, OR
Master’s degree in science, engineering, or other relevant discipline and 5 years relevant experience.
Skills
Extensive knowledge of FDA medical device quality system regulations and international quality system standards/regulations (e.g., 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products.
Experience with risk management tools such as FMEA, Fault Tree Analysis, or Hazard Analysis.
Excellent written and verbal communication skills.
Detail‑oriented with strong organizational and analytical skills.
Location USA NJ - Franklin Lakes
Salary Range $130,400.00 - $215,200.00 USD Annual
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.
#J-18808-Ljbffr