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.
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.
Make effective use of statistical techniques, risk analysis, Gage R&R, Cpk, ANOVA and DOE to solve quality problems and mitigate product and process risks.
Make use of Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D and other problem solving techniques.
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
Travel for supplier and R&D support
Mentor other members of the quality assurance team in statistical and problem solving techniques.
Execute cross functional projects using project management methodologies such as critical path methodology, critical chain.
Identify and prioritize continual improvement ideas.
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 is committed to the spirit and letter of the Americans with Disabilities Act and, as required by law, will reasonably accommodate otherwise qualified individuals.
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 Mechanical or Biomedical engineering or equivalent experience; advanced degree is preferred
Very good written and verbal communication skills.
At least 8 years of quality engineering experience.
Good written and verbal communication skills.
Experience working in a production environment
Proficiency with Microsoft Office tools.
Proficiency with basic statistics (mean, standard deviation, etc.).
Experience working in medical device or another regulated industry.
Experience with mechanical inspection techniques and/or metrology.
Experience as an internal, external, or supplier quality auditor.
Ability to apply statistical tools to quality problems.
Proficiency with Minitab statistical software.
Experience with root cause analysis and corrective and preventive action.
Proficiency at reading engineering drawings and schematics.
Experience with biocompatibility and sterilization testing.
Desirable additional qualifications:
Familiarity with ISO 13485, EU MDR, and 21 CFR Part 820
Lean Six Sigma experience
ASQ Certified Quality Engineer
Knowledge of Geometric Dimensioning and Tolerancing
Experience developing process metrics
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.