We are hiring a Quality Engineer to join our growing team in Raynham, MA in this on-site position. As a QE, you will provide 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. This is accomplished by establishing, updating, and maintaining Corin USA's principles of Safety, Quality, Customer Satisfaction and Innovation.
The key responsibilities of the 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.
- Responsible for supporting and maintaining the equipment calibration system, including scheduling, record review, out‑of‑tolerance investigations, and audit support, ensuring compliance with ISO 13485 and MDSAP requirements.
- Prepare for and support internal and external audits by ensuring audit readiness, compiling objective evidence, coordinating with process owners, supporting auditor interviews, and assisting with timely corrective action responses in alignment with MDSAP requirements.
- Apply 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.
- 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.
The ideal Quality Engineer will have/be:
- A Bachelor's Degree (B. S.) in Life Sciences or Engineering, or equivalent experience 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.
- 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 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 salary range is $65-85k with a variable compensation package. 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.