Senior Quality Engineer

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.

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
• Manage Quality staff to including recruitment, goal setting, ongoing performance assessment, training, coaching, and professional development

The ideal Senior Quality Engineer will have/be:

• 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

The base pay range for this position is $90,000-110,000. The specific pay offered may be influenced by a variety of factors, including the candidate’s experience, education, and skill set.

Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.