Quality Engineer

About the role

Our Quality Engineer will proactively drive quality and compliance in the production support area in a collaborative way. This position represents an exciting opportunity to join an innovative and high performing team and influence the design and development in early stages.

Responsibilities

• Direct support of batch release testing and maintenance. Includes data analysis and interpretation.
• Responsible for oversight of batch release equipment including reviewing equipment calibration / preventive maintenance, and investigation and disposition of equipment events.
• Collaborate closely with cross-functional teams, including Operations and R&D.
• Support Operations including Nonconforming Materials Reports (NCMR) investigation, identifying appropriate corrective actions and disposition of material.
• Work closely with and provide technical guidance to quality technicians.
• Support development of risk management file and associated deliverables, such as PFMEA and Master Validation Plan.

Skills & Hands-On Experience

• Excellent communication skills: ability to work both independently and in project team setting.
• Experience with electromechanical systems is preferred.
• Good attention to detail is required.

Requirements

• B.S. or higher in Biomedical, Electrical, Mechanical or Systems Engineering or equivalent relevant work experience.
• 2-5 years of experience in an engineering role.
• Experience in the medical device industry with electromechanical products and/or interventional cardiology products is preferred.
• Familiarity with the concepts of test method validation, process validation, and Design Verification including statistical techniques and data analysis.
• Experience with software is desired.
• Exposure to Risk Management for medical devices.
• Exposure to medical device regulations, including FDA QSR, 13485, EU MDR etc.

Qualifications

The base salary range for this full-time position is between $95,000 to $120,000 + equity + benefits.