Quality Engineer

Job Description

We are the people who give possibilities purposeBD 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 Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

• Provide quality engineering support for manufacturing processes to ensure compliance with FDA regulations, ISO standards, GMP requirements, and company quality system procedures.
• Lead and support investigations related to nonconformances, deviations, customer complaints, out-of-specification results, audit findings, and other quality events to determine root cause and implement effective corrective and preventive actions (CAPA).
• Evaluate manufacturing processes and quality data to identify trends, improve process capability, reduce defects, and drive continuous improvement initiatives.
• Develop, review, and approve quality documentation, including procedures, work instructions, specifications, protocols, reports, risk assessments, and validation documentation.
• Support product and process validation activities, including IQ/OQ/PQ, process validation, cleaning validation, software validation, and test method validation, as applicable.
• Participate in change control activities by assessing the quality and regulatory impact of proposed changes to products, processes, materials, equipment, and systems.
• Utilize quality engineering tools and methodologies, including statistical analysis, process capability studies, root cause analysis, Failure Mode and Effects Analysis (FMEA), and risk management techniques.
• Analyze quality metrics and performance indicators, including scrap, yield, nonconformances, complaint trends, and process performance data, and recommend improvement actions.
• Collaborate with Manufacturing, Engineering, Operations, Regulatory Affairs, Supply Chain, R&D, and Validation teams to ensure quality requirements are incorporated into products and processes.
• Support internal audits, supplier audits, customer audits, and regulatory inspections, including the development and implementation of corrective actions resulting from audit observations.
• Develop, improve, and validate inspection and test methods to ensure reliable and accurate evaluation of product quality.
• Ensure that risk management principles are incorporated into quality and manufacturing processes throughout the product lifecycle.
• Monitor customer feedback, complaints, and post-market quality data to identify opportunities for product and process improvements.
• Provide technical guidance and quality training to manufacturing personnel and quality staff regarding quality requirements, procedures, and best practices.
• Support regulatory submissions, FDA inspections, notified body audits, and other regulatory activities as required.
• Promote a culture of quality, compliance, continuous improvement, and patient/customer focus throughout the organization.
• Ensure compliance with all applicable safety, environmental, and company policies.
• Perform other duties and projects as assigned.

Education:

Bachelor's degree in Engineering. Master's degree in Engineering Preferred.

Experience:

Minimum of four (4) years of experience in Engineering or Quality Engineering within the medical device, pharmaceutical, or equivalent industry if holding a Bachelor's degree. Minimum of two (2) years of experience in Engineering or Quality Engineering within the medical device, pharmaceutical, or equivalent regulated industry if holding a Master's degree.

• Knowledge of FDA Quality System Regulation (21 CFR Part 820) and/or Pharmaceutical GMP requirements (21 CFR Parts 210/211).
• Knowledge of ISO 13485 and risk management principles (ISO 14971) for medical devices.
• Root Cause Analysis, CAPA, and Investigation Management.
• Process Validation and Test Method Validation.
• Statistical Analysis and Process Capability.
• Change Control and Risk Assessment.
• Audit Readiness and…