Corin Senior Quality Engineer - US in Raynham, Massachusetts
Senior Quality Engineer required for quality leadership and direction to meet customer quality requirements, create, monitor, and improve quality systems, reduce quality costs and maintain compliance within FDA and ISO regulations.
Do you have a mechanical or biomedical engineering degree, time served experience within a quality assurance role in orthopaedic / medical devices or arthroplasty and experience in the use of statistical and other quality tools for investigation processes? Then apply now!
The key job responsibilities for the Senior Quality Engineer will be to:
Proactively investigates, identifies, and implements best-in-class Quality System practices.
Develop and maintain 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.
Manage the supplier quality program
Lead/support internal and external audits.
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 Senior Quality Engineer will have:
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, EN ISO 13485, Directive 93/42/EEC, EU MDR.
A minimum of three years’ experience in Quality Engineering.
Demonstrated understanding of Engineering dimensioning and tolerancing, calibration, product development and implementation, supplier qualification and development, and Quality Engineering.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
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