What are the responsibilities and job description for the Quality Engineer position at Microline Surgical?
JOB SUMMARY : Maintain the quality system and support outgoing product quality 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.
- Good understanding of statistical techniques, risk analysis, Gage R&R, Cpk, ANOVA and DOE.
- Good problem solving experience with Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D.
- Approve Engineering Change Orders, review prints and be familiar with Geometric Tolerancing.
- Maintain Quality Records.
- Perform Corrective Actions and Non-conformance assessments.
- Assist in investigating customer complaints.
- Perform internal audits as well as supplier audits.
- Support Incoming Inspection.
- Review Work Instructions, Quality Plans, FMEAs, specifications, drawings, quality systems and analysis trends.
- Participate in and lead continual improvement projects
- Support environmental and sterilization monitoring
- Some travel required for supplier support
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 :
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.
