Quality Engineer II

We are the makers of possible at BD, a global medical technology company. We advance the world of health by continually evolving and finding transformative solutions. Join us and become a maker of possible.

Requirements

• Leads development of risk assessments and test methods
• Supports component qualifications, design validation / verification and process validation
• Leads basic level product investigations
• Ability to make and present risked based decisions
• Assess product changes against product design
• Supports translation of design inputs into manufacturing control plans
• Quality Engineering representation on Product Development Teams.
• Participate and provide guidance to training on department/division procedures, and policies.
• Participate in project planning, budgeting, scheduling and tracking.
• Support internal and external supplier audits.
• Develop and implement procedures to align with corporate and industry standards.
• Provide support to the regulatory department in writing technical submissions.
• Provide positive example and actively promote compliance to division, corporate and industry standards.
• Maintain a professional working relationship with internal and external customer and support staff.
• Prepare and present project updates and technical discussions.
• Support 'Voice of the Customer' identification and translation into design inputs.
• Knows how products are used and impact the user(s) so that risk can be handled optimally.
• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc...)
• Support remediation and regulatory requirements including MDSAP/EUMDR.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship