Senior Quality Engineer

Senior Quality Engineer

Requirements

• Bachelor’s Degree in Engineering, Science or technical field
• 4+ years of work experience in Engineering, Quality, and/or experience in a regulated industry OR Advanced Degree in Engineering, Science or technical field with 2+ year of work experience in Engineering, Quality, and/or experience in a regulated industry.

Responsibilities

• Collaborates with R&D, Regulatory, Operations, and Process Engineering to ensure high reliability and safety for NV products, and compliance to NV’s Quality system procedures.
• Implements and validate methods and procedures for inspections and Validation testing.
• Performs statistical analysis to support quality decisions.
• Support CAPA and NCR dispositions. Support Field Corrective Actions and product holds. Support Issue Investigations across Released Product Engineering. Support Remediation projects and Design and Process changes.
• Ensure design control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
• Work with vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and guide wires to ensure quality products.
• Utilize Statistical analysis tools including DOE (Design of Experiments), SPC (Statistical Process Control), ANOVA (Analysis of Variance), t-test, Process Capability, Confidence & Tolerance interval analysis with proficiency in Minitab.
• Coordinate Product and Process risk utilizing Process Failure Mode Effects and Criticality Analysis (PFMECA) and Design Failure Mode Effects and Criticality Analysis (DFMECA).
• Navigate government and industry standards to include FDA 21CFR part 820, ISO13485, ISO14971 and Good Documentation Practices (GDP).
• Provide Process Verification & Validation for product quality, including development and execution of protocols Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) and TMV (Test Method Validations)).
• Coordinate root cause analysis using various quality tools (5 Whys, 6M and Ishikawa (Fishbone) Diagram). Participate in CAPA (Corrective and Preventive Actions) and implementation of corrective and preventive actions as necessary.
• Identify Critical to Quality (CTQ) product features and sampling methods as well as interpreting engineering drawing and GD&T (Geometric Dimensioning and Tolerancing).
• Create, Maintain, and implement Risk Management processes across products and processes.

Preferred Qualifications

• Very Strong Test Method development and Validation skills/experience
• Prior experience in medical device design quality
• Strong Technical experience (Polymers, Material Science and strength of Materials)
• Working Knowledge of medical device regulatory laws and standards
• Experience with inspection plans and inspection tools/equipment qualification
• Experience managing product nonconformance (disposition, rework, closure)
• Experience with QAD & SAP enterprise resource planning systems
• Six sigma certification / ASQ certifications
• Masters of Science or PhD in Engineering or Material Science, Polymers, Chemistry