Senior Engineer, Quality Engineering

BS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Process

Engineering, or related technical disciplines. An MS degree is preferred.

Demonstrated experience in quality oversight and management of products through the lifecycle of product development.

Experience supporting quality systems, practices, and policies.

Familiarity with regulatory requirements including US CFR (Code of Federal Regulation), ISO (International Organization for Standardization), GMP (Good Manufacturing Practice), and EU MDR (Medical Device Regulation).

Knowledge of FDA 510(k) clearance, FDA Premarket Approval (PMA), and ongoing submission maintenance requirements.

Experience with the use of quality systems and tools (for example, CAPA, Six Sigma methodology, change control, Statistical Analysis, Control Plans, and document management)

Experience supporting Risk Management, for instance, ISO 14971 standard.

Experience directing root cause analysis using quality tools, such as 5 Why, Fishbone Analysis, and Fault Tree Analysis.

For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process.

Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.

EEO is the Law: Notice of Applicant Rights Under the Law.

Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors.

This position qualifies for a discretionary performance-based bonus which is based on personal and company factors.

This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.