Microline Surgical develops and manufactures high precision open and laparoscopic surgical instruments. Microline’s laparoscopic reposable instruments provide a cost-effective, eco-friendly solution for today’s OR.
SUMMARY: Maintain the quality system and support supplier and incoming quality through the use of engineering tools and methodologies in order to support production, design, and development of medical devices.
The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.
Work with suppliers and the Purchasing department to address quality issues with raw materials and components.
Maintain supplier approvals and certifications.
Review supplier quality agreements.
Make use of statistical techniques,risk analysis, Gage R&R, Cpk, ANOVA and DOE
Solve problems using Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D.
Maintain Quality Records.
Perform Corrective Actions and Non-conformance assessments.
Perform supplier audits as well as internal audits.
Support Incoming Inspection.
Review Work Instructions, Quality Plans, FMEAs, specifications, drawings, quality systems and analysis trends.
Participate in and lead continual improvement projects.
Travel up to 25% required for supplier support and audits.
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.
Microline Surgical is an Equal Opportunity Employer/Minorities/Women/Veterans/Disabled/Sexual Orientation/Gender Identity company. Employment is contingent upon successful completion of background and drug screening.
Bachelor’s Degree in Industrial, Mechanical or Biomedical engineering or equivalent experience.·
Very good written and verbal communication skills.·
At least 5 years of experience working with suppliers; preferably in the medical device or other regulated industry.·
CQA or certified biomedical auditor certification helpful but not required.·
Experience with supplier audits and supplier management.·
Experience with quality management systems standards (ISO13845, ISO9001, AS9100)·
Accuracy, thoroughness, attention to detail, legibility in completing records is essential.·
Lean and 6Sigma knowledge a plus.
Telecommuting is allowed.
About Microline Surgical
Founded in 1987, Microline is a wholly owned subsidiary of HOYA Corporation in Tokyo, Japan. Starion Instruments™ Corp. was acquired by Microline Group in 2009 and officially merged in 2011. Microline Surgical designs, develops, manufactures, and markets a broad range of minimally invasive surgical instruments that enhance performance, minimize risk and improve patient outcomes worldwide.
Microline's product portfolio comprises of cutting, dissecting, grasping, cauterizing and ligating instruments used in all laparoscopic surgical disciplines, including General Surgery, Gynecologic Surgery, Urologic Surgery, and Bariatric Surgical procedures.