Design Quality Engineer II

About the role

PurposeBD is seeking a Design Quality Engineer II to develop and maintain inspection methods, support design projects, and ensure compliance with the Quality Management System across product development and manufacturing.

Key responsibilities

• Develop and maintain methods and sampling procedures for inspections, testing, and evaluation.
• Support design‑related projects to ensure compliance with QMS requirements.
• Review and approve design control documents such as Design Verification, Design Validation, and technical summaries.
• Perform residual risk assessments and post‑market surveillance activities.
• Manage change control for process improvements while maintaining design intent.
• Investigate manufacturing quality issues (CAPA, non‑conformances, audit observations) and generate reports.
• Support product and process transfer projects and ensure validation/qualification of equipment and processes.
• Lead continuous‑improvement initiatives using Six Sigma, SPC, Kaizen, DOE, and other quality tools.
• Analyze data to provide recommendations and lead multifunctional risk‑assessment teams.

Required profile

• Strong knowledge of quality engineering principles and regulatory requirements for medical devices.
• Experience with Quality Management Systems and design control processes.
• Proven ability to conduct risk assessments, CAPA investigations, and change‑control activities.
• Hands‑on experience in validation, qualification, and equipment/process compliance.
• Ability to work cross‑functionally on project management and continuous‑improvement initiatives.

Required skills

• Six Sigma
• Statistical Process Control (SPC)
• Design of Experiments (DOE)
• Risk assessment methodologies
• CAPA management
• Change control processes
• Validation/qualification procedures
• Data analysis