Quality Engineer

SCIENTIA VASCULAR INC•West Valley City, UT

About The Position

Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and microfabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients. Quality Engineer Role: This position assures that new product designs and the processes for manufacturing them meet all requirements with respect to safety and efficacy. This individual will be active on new product development and ongoing manufacturing activities. This role will prioritize a focus on test method development, measurement system analysis, and test method validation.

Requirements

Bachelors or Master of Science Degree in Engineering or Technical Sciences or equivalent work experience and/or professional qualifications.
Experience with Quality in a manufacturing environment.
Knowledge and experience with advanced quality systems, concepts, regulatory compliance requirements and applied statistical concepts.
Demonstrated knowledge of interpretation and application of QSR, MDD, ISO 13485 and other international standards.
Good oral and written communication skills

Nice To Haves

Demonstrated experience and success in test method development and validation
3-7 years of industry experience

Responsibilities

Develop or assist in development of inspection and test methods per product specifications.
Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors.
Development of Test Protocols and Final Report to support Regulatory 510K, PMA, CE mark and international registrations.
Support Pre-Concept Front End Product Innovation Process activities for new technologies.
Lead Quality Engineering Projects to improve Quality systems and Procedures.
Assist with the development of the Design Validation Protocol and the subsequent Design Validation Report including an analysis of all data and a decision on design acceptability.
Provide input into the project Failure Modes and Effects Analysis, Device Master Record, Risk Analysis, Risk Benefit, Risk Management Plan and Risk Management Report for the product development process.
Determine the degree of Biocompatibility testing required as per ISO10993 and company procedures. Co-ordinate the testing at an outside lab and document results.
Assist in the development test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating.
Design and qualify inspection test methods and equipment.
Develop and document the Quality Management System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product.
Support the development of FMEAs.
Perform and/or Support Process Development Studies to determine the acceptability of new processes or equipment.
Support Process Transfers to the Production facilities.
Conduct investigations of rejected nonconforming components and products; conduct NCR action when required.
Conduct other Quality Control Projects as assigned by the Manager of Advanced Quality Engineering.
Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted.
Other duties as assigned with or without accommodation.