Quality Systems Engineer, Medical Devices & Training

Analog Devices, Inc.; Wilmington (MA); On-site; USD 75,200 - 103,400; Full time

Benefits offered by this job

Medical coverage

Vision coverage

Dental coverage

401k

Paid vacation

Holidays and sick time

Job summary

Analog Devices, Inc. is seeking a Quality Systems Engineer in Wilmington, MA to develop and maintain quality management systems for medical devices. Responsibilities include supporting compliance with ISO 13485 and FDA regulations, coordinating training activities, and conducting internal audits.

The ideal candidate should hold a Bachelor’s or Master’s degree in relevant engineering fields and possess strong analytical and communication skills. Experience in quality engineering in the medical device industry is preferred.

Qualifications

• Understanding quality management principles and regulatory requirements in the medical device industry.
• Internship or co-op experience in a quality engineering role within the medical device industry (preferred).
• Knowledge of statistical analysis and quality improvement tools (e.g., Six Sigma, Lean) (preferred).

Responsibilities

• Assist in the development and maintenance of Medical Quality Management System (MQMS).
• Support quality system processes including CAPA, Internal Audits, and Document Control.
• Participate in internal and external audits to ensure compliance.

Skills

Analytical skills

Problem-solving

Communication skills

Microsoft Office Suite

Education

Bachelor’s or Master’s degree in Biomedical Engineering, Manufacturing Engineering, Electrical Engineering, or related field

Tools

Quality management software

Job description

Analog Devices, Inc. is seeking a Quality Systems Engineer in Wilmington, MA to develop and maintain quality management systems for medical devices. Responsibilities include supporting compliance with ISO 13485 and FDA regulations, coordinating training activities, and conducting internal audits.

The ideal candidate should hold a Bachelor’s or Master’s degree in relevant engineering fields and possess strong analytical and communication skills. Experience in quality engineering in the medical device industry is preferred.