Quality Engineer II: MedTech Design & Validation

Becton Dickinson NA; Covington (GA); On-site; USD 80,000 - 110,000; Full time

Job summary

Becton, Dickinson and Company in Covington, GA is seeking a Quality Engineer II to support product development, design changes, validation, and quality system activities to ensure regulatory compliance and product quality.

This role serves as the Quality representative on cross-functional project teams, applying Design Controls, risk management, and validation principles across the product lifecycle, with experience in FDA-regulated industries preferred.

Qualifications

• Working knowledge of Quality Management Systems and regulatory requirements.
• Understanding of Design Controls and risk management principles.
• Experience writing and executing process, software, equipment, or product validation protocols.
• Strong written and verbal communication skills with the ability to work effectively on cross-functional teams.

Responsibilities

• Serve as the Quality representative on product development and process change project teams.
• Ensure Design Control requirements are applied to new product development and product or process changes.
• Support design transfer and product lifecycle activities with cross-functional teams.
• Create, review, and maintain documentation required for Design History Files (DHF).
• Create, review, and maintain Quality System documentation, including procedures, work instructions, and records.
• Generate and support quality documentation, including RFS, ECR, PQR, and related quality records.
• Ensure compliance with corporate, divisional, and departmental procedures.
• Create and review validation documentation including: Process Validation Protocols, Product Validation Protocols, Stability Protocols, Test Methods, Validation Reports.
• Support equipment, process, software, and product validation activities.
• Develop and review risk assessments, including FMEA, FMECA, Fault Tree Analysis.
• Participate in internal and supplier quality audits.
• Support Quality Management System compliance activities.
• Assist in maintaining compliance with FDA regulations and applicable quality standards.
• Support continuous improvement initiatives related to quality and compliance.

Education

Bachelor's degree in Engineering, Engineering Technology, Science, or a related technical discipline

Job description

Becton, Dickinson and Company in Covington, GA is seeking a Quality Engineer II to support product development, design changes, validation, and quality system activities to ensure regulatory compliance and product quality.

This role serves as the Quality representative on cross-functional project teams, applying Design Controls, risk management, and validation principles across the product lifecycle, with experience in FDA-regulated industries preferred.