Quality Engineer II - Sustaining Quality & NPI

About the role

The Quality Engineer II supports sustaining quality for existing manufacturing processes and products, keeping them compliant with customer, regulatory and QMS requirements. The role also covers NPI, product transfers, process validations and other quality projects, working with cross-functional teams in a fast-paced manufacturing environment.

Key responsibilities

• Serve as the main quality interface for assigned manufacturing operations, leading or supporting nonconformance investigations, root cause analysis, CAPA and customer complaint investigations
• Analyze quality data and trends, and support process controls, inspection methods, sampling plans and acceptance criteria
• Support process and equipment changes, including risk assessments, qualification and revalidation, and maintain PFMEAs and control plans
• Lead or support NPI and product transfer activities, and develop IQ/OQ/PQ process validations
• Contribute to the QMS, support internal, customer and regulatory audits, and take part in supplier quality activities
• Implement continuous improvement initiatives and provide technical guidance to quality personnel

Required profile

• Bachelor's degree in Engineering or a related technical field (Mechanical, Industrial, Biomedical or similar)
• 4+ years of quality engineering experience in medical device or regulated manufacturing
• Bilingual English and Spanish at advanced level (B2+ minimum)
• Experience in machining, molding, assembly or similar manufacturing environments
• Desirable: NPI/product transfer, supplier quality and audit experience; ASQ CQE/CQA or ISO 13485 Internal Auditor certification; ERP/MES familiarity (e.g. Epicor)

Required skills

• ISO 13485 and FDA 21 CFR 820
• PFMEA, control plans, IQ/OQ/PQ and statistical methods
• Microsoft Office