Quality Engineer II

About the role

The Quality Engineer II supports new product development and sustaining activities through the application of Quality engineering skills for medical devices. They also review, assess, and coordinate Quality Notifications and Deviations for the Reagents plant, providing critical quality engineering direction and conducting complaint investigations.

Responsibilities

• Supports new product development and sustaining activities through Quality engineering skills for medical devices.
• Understand, improve, and control operational processes to realize predictable product flow while satisfying established BD standards of quality.
• Reviews, assesses, and coordinates Quality Notifications and Deviations for the Reagents plant.
• Provides critical quality engineering direction with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, CAPA and validations.
• Conducts complaint investigations to identify Root Cause, assists in the investigation of manufacturing issues, and provides data and input on technical issues and projects.

Requirements

• Experience in an ISO 9001 or ISO 13485 environment.
• Nonconforming Product or Customer Complaint experience.
• Ability to multitask and work semi-independently.

Qualifications

• Bachelor’s or Master’s degree in a related field required.
• Two years of experience or a Master’s degree with no experience required.
• Lifesciences degree, Professional Quality certification (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.), and SAP ERP experience preferred.

Skills

• Practical and working understanding of pertinent Quality Systems Regulations (e.g., Good Manufacturing Practices, ISO9001 and ISO 13485).
• Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
• Microsoft program proficiency and ability to learn other systems.
• Working knowledge of statistical methods and statistical application software.
• Effective verbal and written communication skills.
• Self-motivated/directed, organized, detail-oriented, and able to multi-task projects.
• Teamwork and independent project capability.

Pay

Details TBD.

Schedule

8am-5pm, 40 hours/week.