New Product Development Quality Engineer II

The Quality Engineer New Product Development (NPD) is responsible for supporting all quality engineering activities to support the new product life cycle, from concept through commercialization and sustaining changes, as part of a cross-functional development team. Serves as the key resource for ensuring compliance to ISO, MDD and QSR requirements for Medical Devices. Takes the lead with quality initiatives with inter-organizational impact following QSR, ConMed Policies and standards. Works under direction from Quality Management.

Duties and Responsibilities:

• Quality Engineer supports and provides direction to product development teams as to the required quality deliverables ensuring that product design and processes meet customer expectations, regulatory requirements, appropriate voluntary standards and all corporate and divisional requirements with respect to safety and efficacy.
• Leads and provide support on risk management activities for new and sustaining engineering projects. Demonstrate quality assertiveness and be able to represent the Quality function in various roles such as product support and lifecycle management.
• Review, assess and approve product design milestones, DHF and deliverables to ensure compliance throughout product development cycle.
• Supports and provides guidance to Manufacturing Engineers during the process development and validation activities. Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields.
• Support post market activities such as complaint investigation, complaint trending. Performs Predicate Device reviews and surveillance reports. Able to perform data mining, trend reports (Oracle, Report Builder, Crystal and DMAIC).
• Provides guidance about Six Sigma principles (Sampling, Acceptance Criteria, DOE, Statistical Process Control, Root Cause Analysis, FMEA, control charts, capability analysis)
• Provides support in change management tasks, process improvement efforts and supplier changes.
• Initiates and leads investigations as part of the CAPA Process for product/process non-conformances, customer complaints, and internal audits in concert with other departments (i.e. R&D, Manufacturing, Service, Purchasing, etc.).
• Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.