Spec 3 Quality Assurance Engineer

About the role

Join embecta, a global diabetes care leader, as a Spec 3 Quality Assurance Engineer. You will help shape and maintain quality systems that support new business models, product distribution, and third‑party collaborations.

Key responsibilities

• Develop and implement Quality Management System (QMS) processes for emerging business models.
• Create SOPs, work instructions, and process maps for new product introductions (NPI) and distribution.
• Support quality integration for distributed and third‑party products.
• Define governance models and oversight frameworks for distributed products.
• Establish distribution quality processes, monitoring frameworks, and threshold‑based escalation criteria.
• Harmonize complaint handling workflows and define complaint versus non‑complaint criteria.
• Support supplier qualification frameworks and work cross‑functionally on regional and global projects.
• Conduct risk assessments aligned with ISO 14971.
• Assist with audit readiness and regulatory compliance.

Required profile

• Experience with quality management systems in a regulated environment.
• Familiarity with ISO 14971 risk management standards.
• Ability to develop SOPs, work instructions, and process documentation.
• Strong cross‑functional collaboration skills.

Required skills

• Quality Management Systems (QMS)
• ISO 14971 risk assessment
• SOP and work instruction development
• Complaint handling processes

What we offer

• Competitive total rewards package including pay, benefits, and continuous learning.
• Inclusive, growth‑centered culture.
• Opportunities to work with inspirational leaders and global teams.