Quality Systems Engineer — Medical Devices & Training

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

Benefits offered by this job

Medical, vision and dental coverage

401k

Paid vacation, holidays, and sick time

Discretionary performance-based bonus

Job summary

Analog Devices in Wilmington, Massachusetts is on the lookout for a Quality Systems Engineer to develop and maintain quality management systems for medical devices. This role encompasses responsibilities as a Training Coordinator for the Quality Engineering group, ensuring compliance with ISO 13485 and FDA regulations.

The ideal candidate will possess a degree in a relevant engineering field and demonstrate excellent problem-solving and communication skills. A comprehensive benefits package is included, along with an expected wage range of $75,200 to $103,400.

Qualifications

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

Responsibilities

• Support development and maintenance of quality management systems for medical devices.
• Organize and schedule training sessions for team members.
• Conduct internal and external audits, ensuring compliance with regulatory standards.
• Collaborate with cross-functional teams to ensure product quality and safety.

Skills

Analytical skills

Problem-solving

Communication skills

Interpersonal skills

Quality management knowledge

Education

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

Tools

Microsoft Office Suite

Quality management software

Job description

Analog Devices in Wilmington, Massachusetts is on the lookout for a Quality Systems Engineer to develop and maintain quality management systems for medical devices. This role encompasses responsibilities as a Training Coordinator for the Quality Engineering group, ensuring compliance with ISO 13485 and FDA regulations.

The ideal candidate will possess a degree in a relevant engineering field and demonstrate excellent problem-solving and communication skills. A comprehensive benefits package is included, along with an expected wage range of $75,200 to $103,400.