Quality Engineer II - NPI and Validation

About the role

The Quality Engineer II reviews and approves risk management documentation, process validation activities and quality-related project deliverables. The role owns the Measurement System Analysis (MSA) and Incoming Inspection programs and acts as a key quality liaison with customers throughout the new product introduction (NPI) lifecycle.

Key responsibilities

• Review and approve PFMEAs and other risk management documentation produced by project teams.
• Review and approve process validation protocols and reports, including IQ, OQ and PQ activities.
• Own the MSA program, ensuring the adequacy, execution and maintenance of measurement system studies.
• Manage the Incoming Inspection program, including inspection plans, acceptance criteria and effectiveness monitoring.
• Audit project activities and quality deliverables against internal procedures, regulatory requirements and quality standards.
• Take part in NPI projects, design reviews and manufacturing transfer as the Quality representative.
• Identify quality risks and escalate concerns affecting product quality, compliance or project timelines.
• Support internal, customer and regulatory audits and monitor and report quality metrics.
• Act as the primary quality contact for customers, updating them on risk management, validation, inspection strategies, nonconformances and corrective actions, and taking part in customer meetings.

Required profile

• Bachelor's degree in Engineering or a related technical field.
• At least 3 years of experience in Quality Engineering within a regulated manufacturing environment.
• Experience supporting NPI, technology transfers or process implementation projects.
• Familiarity with ISO 13485, FDA QMSR or equivalent regulatory standards.
• Advanced English communication skills.

Required skills

• PFMEA, IQ/OQ/PQ validation, MSA and incoming inspection
• Quality systems compliance and auditing
• Analytical, organizational and cross-functional collaboration skills