Senior Manager, Quality Engineering

Role Overview

• Lead review and approval of technical and engineering documentation including: DMR, DHF elements, IQ/OQ/PQ, Process validations and qualifications
• Provide quality oversight for: New production line establishment, Process validation activities, Engineering changes (ECO/DCO)
• Oversee production quality controls including: Raw material approval, Calibration approval (including deviations)
• Lead the site’s customer complaints handling process: Investigation and root cause analysis, Risk-based evaluation
• Set priorities and objectives for Quality Engineering and Compliance teams
• Promote a strong 'Quality First' culture throughout the organization

Requirements

• B.Sc. in Engineering, Science, Chemistry, Biology or related discipline
• 8–10+ years of experience in Quality roles within Medical Device industry
• Proven experience in Design controls, Process validation, Risk management
• Strong knowledge of ISO 13485, MDR 2017/745, MDSAP, ISO 14971, 21 CFR 820
• 5+ years of people management experience, preferred experience of managing team leaders
• MasterControl, SAP, SharePoint, Statistical tools, Proficient in Microsoft Office Suite

Benefits

• health insurance
• retirement plans
• paid time off
• flexible work arrangements
• professional development