Associate Quality Engineer

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

At Microline, we are on a mission to improve the quality of life for everyone. To do that, we seek the best talent to expand and improve our team of dedicated, innovative employees.

Notice to Recruitment Agencies and Headhunters:

Microline Surgical does not accept unsolicited resumes from agencies or third-party recruiters. Any unsolicited resumes or candidate information submitted to us, or to any of our employees, will be considered property of Microline Surgical without any obligation to pay referral or placement fees. To ensure our recruitment team has full visibility into open roles, we ask that all agencies and third-party recruiters adhere to our formal recruitment process and directly reach out to our HR department for any potential partnership.

JOB SUMMARY: Assist in maintaining the quality system through the use of engineering tools and methodologies in order to support production, design, and development of medical devices.

ESSENTIAL FUNCTIONS: The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.

• 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.

NON-ESSENTIAL FUNCTIONS:

In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor.

Qualifications

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.

REASONABLE ACCOMMODATION:

Microline is committed to the spirit and letter of the Americans with Disabilities Act and, as required by law, will reasonably accommodate otherwise qualified individuals.