Associate Quality Engineer — Medical Devices & Impact

Microline Surgical; Beverly (MA); Hybrid; USD 65,000 - 95,000; Full time

Job summary

Microline Surgical in Beverly, MA is seeking a Quality Engineer to maintain the quality system and support production, design, and development of medical devices. The role focuses on risk analysis, process improvements, root cause analysis, CAPA, and ensuring compliance with ISO 13485 and 21 CFR Part 820.

Collaboration with cross-functional teams and participation in continual improvement initiatives are essential.

Qualifications

• Bachelor’s degree in Engineering, Science, or Math or equivalent experience.
• Good written and verbal communication skills.
• Up to 2 years of previous engineering or technician experience.
• Proficiency with Microsoft Office tools.
• Proficiency with basic statistics (mean, standard deviation, etc.).
• Familiarity with ISO 13485, EU MDR, and 21 CFR Part 820.
• Experience in medical device or another regulated industry.
• Ability to apply statistical tools to quality problems.
• Experience with root cause analysis and corrective and preventive action.
• Experience working in a production environment.
• Proficiency at reading engineering drawings and schematics.

Responsibilities

• Assist in the design and development of new products by contributing to risk analysis, verification and validation test plans, etc.
• Make use of Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D and other problem solving techniques.
• Maintain Quality Records.
• Perform Corrective Actions and Non-conformance assessments.
• Perform internal audits.
• Review Work Instructions, Quality Plans, FMEAs, specifications, drawings, quality systems and analysis trends.
• Participate in continual improvement projects
• Support environmental and sterilization monitoring
• Identify continual improvement ideas.

Skills

Written and verbal communication

Statistical analysis

Root cause analysis

Production experience

Reading engineering drawings

Education

Bachelor’s Degree in Engineering/Science/Math

Tools

Microsoft Office

Minitab

Job description

Microline Surgical in Beverly, MA is seeking a Quality Engineer to maintain the quality system and support production, design, and development of medical devices. The role focuses on risk analysis, process improvements, root cause analysis, CAPA, and ensuring compliance with ISO 13485 and 21 CFR Part 820.

Collaboration with cross-functional teams and participation in continual improvement initiatives are essential.