Quality Engineer

The Quality Engineer provides Quality Engineering support for supplier quality, R&D, manufacturing operations, and complaint handling activities across multiple manufacturing sites. This role investigates product and process nonconformances, defines disposition and corrective actions, conducts internal and external audits, and implements quality system improvements in accordance with applicable industry standards, regulatory requirements, and customer requirements.

• The Quality Engineer also defines validation strategies, including Master Validation Plans (MVPs) and validation documentation.
• The following responsibilities represent the primary duties of this role; additional duties may be assigned as required.
• Administer supplier quality activities and manage supplier evaluations
• Perform disposition of nonconforming material requiring advanced technical and process knowledge
• Investigate product and process nonconformances and define corrective actions
• Lead, train, and participate in root cause investigations for nonconforming products and processes
• Perform detailed root cause investigations of failed products or processes
• Plan and implement quality projects and procedures to improve processes, increase product quality and reliability, and ensure regulatory compliance
• Implement quality system improvements in accordance with applicable industry standards, regulatory requirements, and customer requirements
• Write, review, and approve validation files (protocols and reports) for validation of new or modified equipment, processes, and test methods
• Define and support validation strategies, including Master Validation Plans (MVPs) and validation documentation
• Partner with Operations Management, Manufacturing, and R&D Engineering to integrate new or improved products and processes into manufacturing operations
• Plan, conduct, and participate in internal and external audits
• Ensure compliance with applicable GMP and international regulatory standards, including ISO 13485 and MDR 2017/745
• Perform other duties as assigned

• Minimum of 3–5 years of related work experience in the medical device industry
• Knowledge of GMP, QSR, ISO 13485, and MDR 2017/745
• Ability to read and interpret controlled drawings and specifications
• In-depth understanding of manufacturing processes, including inspection and process control
• Proficiency in Windows-based software (Word, Excel, PowerPoint)
• Ability to represent Quality as a member of cross-functional project teams
• High level of integrity
• Demonstrated high sense of urgency
• Ability to multitask
• Ability to problem-solve and perform root cause analysis independently and collaboratively
• Organized with a high level of attention to detail