Job description

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:

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.).
Desirable additional qualifications:
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.
Risk management experience.
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.