Quality Engineer

As a Quality Engineer within the DSP CoE department, you'll be pivotal in ensuring our quality management systems are top-notch. You'll apply quality requirements to support the execution of Operations unit objectives. Your role will involve performing nonconformance investigations, including CAPA records, and leading change controls from initiation through completion. This role requires someone who takes clear ownership of records, makes sure accountability for timelines, and drives timely, sustainable resolutions

Responsibilities

• Apply Quality expertise to support Operations objectives, ensuring compliance with GMP and quality management requirements.
• Lead and manage non-conformance investigations, CAPA records, and Change Controls from initiation through completion, ensuring timely and sustainable resolution of issues.
• Review and maintain quality documentation, procedures, and records, ensuring compliance with regulatory requirements, audits, and internal standards.
• Drive continuous improvement through risk mitigation initiatives, GEMBA walks, data analysis, and quality improvement projects while escalating quality, safety, and compliance risks as needed.
• Support audits and inspections, develop GMP training initiatives, and collaborate with stakeholders to ensure effective communication and execution of quality activities.

Requirements

• HBO degree with 3+ years of relevant Quality, Manufacturing, or GMP-regulated industry experience, including experience leading or supporting quality investigations and change controls.
• Strong knowledge of GMP, CAPA, Change Control, quality systems, root cause analysis, risk management, and data analysis; proficient in MS Office and business applications.
• Excellent communication, stakeholder management, analytical thinking, prioritization, and problem-solving skills; fluent English (B2), highly organized, accountable, adaptable, and able to perform effectively under pressure.

Preferred Skills:

Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy

Hybrid work