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

Preferred Qualifications:

• 3 years experience working in Quality Engineering

• Experience in validation and process controls

• FDA regulation experience

• Experience with ISO 13485 and 21CFR PART820

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Primary Work LocationUSA MA - Woburn

Work ShiftNA (United States of America)

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information