Senior Quality Engineer - Raynham, US

Company: Corin Group
Location: Raynham
Posted on: February 21, 2021

Job Description:

Corin is seeking a Senior Quality Engineer to drive customer quality requirements, create, monitor and improve quality programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This is accomplished by establishing, updating, and maintaining Corin USA's principles of Safety, Quality, Customer Satisfaction and Innovation.Corin is a medical device business with innovative robotically assisted platforms for joint replacement surgery. Corin offers a unique combination of clinically proven hip & knee solutions and world leading technologies, our OMNIBotics & OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, with more consistent results and improved recovery rates.The key responsibilities of the Senior Quality Engineer are to* 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.* Read, analyze, and interpret common scientific and technical journals, US and international regulations and legal documents.* Define problems, collect data, establish facts, and draw valid conclusions.* Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.RequirementsThe ideal Senior Quality Engineer will have * A Bachelor's Degree (B. S.) in a scientific or engineering discipline * Time served experience as a Quality Engineer* 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 an understanding of engineering dimensioning and tolerancing, calibration, product development and implementation, supplier qualification and development, and Quality Engineering.* Strong computer skills including database software and Microsoft Office with particularly strong Excel skills* Highly professional Interpersonal skills - Demonstrated ability to work with individuals at all levels of the organization and with suppliers and customers.Corin USA is an equal opportunity employer. Qualified applicants are considered without regard to age, gender, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity, disability, veteran status.

Keywords: Corin Group, Brockton , Senior Quality Engineer - Raynham, US, Engineering , Raynham, Massachusetts