Quality Engineer II: Design Controls & Validation (MedTech)

BD; Covington (FL); On-site; USD 85,000 - 105,000; Full time

Job summary

BD is a global medical technology leader focused on improving health worldwide. The Quality Engineer II will support product development, design controls, validation, and quality system activities to ensure regulatory compliance and product quality.

The role requires experience in FDA-regulated environments and the ability to work with engineering, manufacturing, and quality teams on new product development and continuous improvement initiatives. Travel may be required.

Qualifications

• Minimum of 3 years of experience in an FDA-regulated industry.
• Experience working within Quality Systems, Quality Assurance, Quality Engineering, Manufacturing Quality, or related functions.
• Working knowledge of Design Controls, validation principles, risk management, and regulatory requirements.
• Experience creating, reviewing, or maintaining technical and quality documentation.
• 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 appropriately applied to new product development and product or process changes.
• Support design transfer and product lifecycle activities through collaboration 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.
• Develop and review product documentation to support regulatory and quality requirements.
• Generate and support quality documentation, including RFs, ECRs, PQRs, and related quality records.
• Ensure compliance with corporate, divisional, and departmental procedures.
• Create and review validation documentation including Process, Product, Stability Protocols, Test Methods, Validation Reports.
• Support equipment, process, software, and product validation activities.
• Develop and review risk assessments, including FMEA, FMECA, and FTA.
• 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.
• Collaborate with manufacturing facilities and other divisional locations to support quality objectives.
• Provide guidance and support to project teams and quality initiatives as needed.
• Travel as required to support project, audit, and quality activities.

Skills

FDA-regulated industries

Quality systems

Design Controls

Validation principles

Cross-functional teamwork

Technical writing

Risk management

Education

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

Job description

BD is a global medical technology leader focused on improving health worldwide. The Quality Engineer II will support product development, design controls, validation, and quality system activities to ensure regulatory compliance and product quality.

The role requires experience in FDA-regulated environments and the ability to work with engineering, manufacturing, and quality teams on new product development and continuous improvement initiatives. Travel may be required.