Manufacturing Quality Engineer II

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.

Responsibilities

• Moderate level application of technical principles, theories, concepts, techniques and quality sciences / tools (e.g. Acceptance sampling theory, statistical process control methods, measurement systems, quality planning, failure analysis, design of experiments, process mapping, hypothesis testing, descriptive statistics, process capability analysis, basic quality tools such as pareto, box plots, histograms, scatter diagrams, risk management, supplier quality management, auditing, design / development tools, process validation, software validation, etc.).
• Represent Quality on new product development projects and support sustaining engineering projects.
• Initiate new or revised documentation.
• Write, review, and approve protocols, reports, and data analysis.
• Participate in complaints investigations (as required).
• Provide audit support (preparation, closure, etc.).
• Communicate across functions / departments for assigned areas of responsibility.
• Understand and follow company procedures and regulatory requirements.

Education & Experience

Required Skills

Optional Skills

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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