Associate Quality Engineer

Responsibilities

• Be a Problem-Solving Detective: Design and conduct comprehensive Quality Engineering studies to identify root causes of quality non-conformances, then drive meaningful changes in processes, tooling, and product design to eliminate issues at their source
• Serve as the Technical Expert: Provide critical technical support to manufacturing teams and suppliers, helping resolve quality challenges
• Lead Qualification Initiatives: Perform thorough qualification studies for new suppliers, components, and cutting-edge inspection test equipment to maintain our high standards
• Master Validation Processes: Plan and execute comprehensive validations (IQ/OQ/PQ) and qualification studies for new and existing equipment, including inspection systems, process equipment, software applications, and components
• Create Quality Documentation: Develop clear, documented instructions for Quality Control inspections, including detailed Inspection Plans, Test Procedures, and Quality Standards that guide our teams
• Bridge Customer Requirements: Evaluate customer specifications and assess our capability to meet and exceed their expectations
• Drive Continuous Improvement: Support broader manufacturing and business objectives by contributing innovative ideas, participating in implementation efforts, and serving on cross-functional committees, teams, and task forces
• Manage Special Projects: Take ownership of quality projects assigned by the Quality Engineering Manager, demonstrating your versatility and leadership
• Ensure Product Conformance: Exercise direct control over quality conformance for products in your assigned areas, maintaining our reputation for excellence
• Handle Material Reviews: Complete Material Review Notices (MRNs), maintain accurate databases, and provide timely reporting to management on quality trends
• Review Critical Documentation: Examine Device History Record (DHR) documentation for compliance and authorize release of components and finished products
• Work in a Regulated Environment: Thrive in our FDA cGMP, GDP, ISO 13485, and MDR-compliant medical device manufacturing facility where quality and compliance are paramount
• Required Qualifications:
• Bachelor's Degree in Engineering field
• 1 years QE Experience
• Experience in CAPA and root cause analysis

Requirements

• 3 years experience working in Quality Engineering
• Experience in validation and process controls
• FDA regulation experience
• Experience with ISO 13485 and 21CFR PART820
• Why Join Us?
• We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
• To learn more about BD visit https://bd.com/careers .
• Required Skills
• Optional Skills
• .
• Primary Work Location
• USA MA - Woburn
• Additional Locations
• Work Shift
• NA (United St

Benefits

Additional Information

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description

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