Quality Engineer II

We are seeking a Quality Engineer II to join our team at BD, a global medical technology company. As a Quality Engineer, you will be responsible for maintaining high quality standards, ensuring regulatory compliance, and leading projects to improve product quality and process control. The ideal candidate will have a BA/BS degree in Engineering, Sciences, Mathematics, or equivalent, and 3 years of work experience in Quality Assurance/Manufacturing. Strong understanding of statistical tools, written and verbal skills, and knowledge of validations and QSRs are preferred.

Requirements

• Serve as a resource to work group and project teams, within the plant and outside the plant relative to quality and regulatory issues.
• Maintain familiarity with the manufacturing processes and products to evaluate the cause and effect of defects and identify trends in process and product quality.
• Provide technical mentorship for projects using the application of pFMEAs, risk mitigation, site validations, DOEs, and other experiments and investigations as assigned.
• Ensure the contents of Validation protocols meet all applicable quality system requirements and product requirements.
• Lead projects/project teams in the use of continuous improvement tools and methodologies such as Six Sigma, 8D, 5-Why, etc.
• Work with assigned manufacturing department(s) to maintain the highest quality standards/requirements.
• Initiate, review, and implement policies and procedures relating to product quality and process control as appropriate.
• Ensure that all activities align with government (OSHA, FDA, ISO, etc.) regulations and corresponding policies/procedures.
• Coordinate machine and process capability studies, analyze data, and submit recommendations.
• Coordinate communication between Unit Quality, Unit R&D, and plant personnel on new products, product improvements, and product issues.
• Provide test and statistical support regarding customer complaint issues and make recommendations on actions to be taken to address the issue.
• Lead MWO / PIC initiation, implementation, and follow-through in support of initiatives within the assigned business team.

Benefits

• Generous Paid Time Off
• 401k Matching
• Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Disability Insurance