BD
Quality Engineer II, New Product Development
Job Description Summary:
This position is accountable for supporting new product development and product maintenance 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 play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
Job Responsibilities
Moderate level application of technical principles, theories, concepts, techniques and quality sciences/tools such as acceptance sampling theory, statistical process control methods, measurement systems, quality planning, failure analysis, design of experiments, process mapping, value stream analysis, hypothesis testing, descriptive statistics, process capability analysis, basic quality tools (Pareto, box plots, histograms, scatter diagrams), risk management, supplier quality management, auditing, design/development tools, process validation, software validation, etc.
Act as a quality representative on new product development projects and sustain engineering projects.
Initiate new or revised documentation.
Write, review, and approve protocols, reports, and data analysis.
May participate in complaint investigations.
Provide audit support (preparation, closure).
Communicate across functions and departments for assigned areas of responsibility.
Understand and follow company procedures and regulatory requirements.
Education and Experience
Bachelor’s degree in Engineering or Science.
Minimum of 2 years of relevant Quality Engineering experience.
Knowledge and Skills
Moderate knowledge of applicable quality, engineering, regulatory, corporate, and unit requirements.
Preferred Skills
Oral and written communication.
Ability to work in cross-functional teams.
Statistical analysis and software (Minitab preferred).
Problem solving.
Risk management tools.
Process validation experience (IQ/OQ/PQ).
Internal/external auditing.
Design Controls.
Workplace Requirements For most roles, a minimum of 4 days of in‑office presence per week is required. Remote or field‑based positions will have different workplace arrangements indicated in the posting.
For certain roles, employment is contingent upon proof of full COVID‑19 vaccination. Testing may be available or required in some locations.
Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
To learn more about BD visit https://bd.com/careers.
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, sexual orientation, gender identity or expression, genetics, disability, military eligibility, or veteran status, and other legally protected characteristics.
#J-18808-Ljbffr
This position is accountable for supporting new product development and product maintenance 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 play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
Job Responsibilities
Moderate level application of technical principles, theories, concepts, techniques and quality sciences/tools such as acceptance sampling theory, statistical process control methods, measurement systems, quality planning, failure analysis, design of experiments, process mapping, value stream analysis, hypothesis testing, descriptive statistics, process capability analysis, basic quality tools (Pareto, box plots, histograms, scatter diagrams), risk management, supplier quality management, auditing, design/development tools, process validation, software validation, etc.
Act as a quality representative on new product development projects and sustain engineering projects.
Initiate new or revised documentation.
Write, review, and approve protocols, reports, and data analysis.
May participate in complaint investigations.
Provide audit support (preparation, closure).
Communicate across functions and departments for assigned areas of responsibility.
Understand and follow company procedures and regulatory requirements.
Education and Experience
Bachelor’s degree in Engineering or Science.
Minimum of 2 years of relevant Quality Engineering experience.
Knowledge and Skills
Moderate knowledge of applicable quality, engineering, regulatory, corporate, and unit requirements.
Preferred Skills
Oral and written communication.
Ability to work in cross-functional teams.
Statistical analysis and software (Minitab preferred).
Problem solving.
Risk management tools.
Process validation experience (IQ/OQ/PQ).
Internal/external auditing.
Design Controls.
Workplace Requirements For most roles, a minimum of 4 days of in‑office presence per week is required. Remote or field‑based positions will have different workplace arrangements indicated in the posting.
For certain roles, employment is contingent upon proof of full COVID‑19 vaccination. Testing may be available or required in some locations.
Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
To learn more about BD visit https://bd.com/careers.
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, sexual orientation, gender identity or expression, genetics, disability, military eligibility, or veteran status, and other legally protected characteristics.
#J-18808-Ljbffr