Senior Quality Engineer

Corin•Raynham, MA

2d•$90,000 - $110,000

About The Position

Corin is seeking to hire a Senior Quality Engineer in our Raynham, MA office. The Senior Quality Engineer will be responsible for providing overall quality leadership and direction to meet customer quality requirements, create, monitor and improve quality programs, reduce quality costs and maintain compliance within FDA and ISO regulations. They will establish, update, and maintain Corin USA’s principles of Safety, Quality, Customer Satisfaction and Innovation. 

Requirements

A Bachelor’s Degree (B. S.) in a scientific or engineering discipline with an In-depth working knowledge of quality systems for medical devices, preferably in orthopedics, including but not limited to:  21 CFR 820, 21 CFR 11, EN ISO 13485,  Directive 93/42/EEC
Demonstrated understanding of Engineering dimensioning and tolerancing, calibration, product development and implementation, supplier qualification and development, and Quality Engineering
Demonstrated ability to read, analyze, and interpret common scientific and technical journals, US and international regulations and legal documents
The ability to define problems, collect data, establish facts, and draw valid conclusions
The ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
Highly professional interpersonal skills
Demonstrated the ability to work with individuals at all levels of the organization and with Suppliers and Customers
Computer skills including database software and Microsoft Office with particularly strong Excel skills

Responsibilities

Proactively investigate, identify, and implement best-in-class Quality Engineering practices
Develop quality assurance specifications, test methods, sampling plans and related written procedures
Support CAPA activities and work in conjunction with CAPA owners in conducting investigations, root cause analysis/determination, action plans and effective checks for the effective and timely completion of CAPAs.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Support the non-conforming material process and participate in MRB meetings/discussions to address and resolve non-conformances related to products and/or processes
Lead internal and external audits and manage supplier quality programs.
Provide technical guidance to QC technicians with regards to inspections activities and drive activities to improve product quality, decrease costs, optimize inspection requirements and increase overall efficiency
Work in accordance with and ensure compliance with the quality system procedures related to areas of responsibility
Lead department specific initiatives and projects as assigned.
Perform other duties as assigned by Quality Management
Manage Quality staff to including recruitment, goal setting, ongoing performance assessment, training, coaching, and professional development