Senior Quality Systems Engineer
Access VascularMassachusetts, United States
Posted May 26, 2026
93000 - 160000 USD
Full Time
About the Company
Founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis.
Job Description
Manage the Access Vascular Inc Quality Management System for a growing start-up company that designs, manufactures, and distributes sterile catheter-, software-, electromechanical-based medical device product families. Provide Quality Engineering support for Operations and Operations Quality projects and tasks.
Requirements
- Bachelor's degree in Engineering, Life Sciences, or a related technical field
- Minimum of 5 years’ of quality systems experience with a medical device manufacturing company
- ASQ Certified Quality Engineer (CQE), Certified Medical Device Auditor (CMDA), or equivalent is a plus
- Lead auditor certification (ISO 13485 or equivalent) is a plus
- Experience with implementing and validating eQMS platforms (e.g., Greenlight Guru, MasterControl, ETQ) is a plus
- Familiarity with IEC 62304 (software lifecycle) and IEC 60601 (electrical safety) is a plus
- Experience supporting 510(k) submissions or technical files for CE marking is a plus
- Prior experience at a startup or early-stage medical device company is a plus
Benefits
- Commensurate With Experience
- Job offers salary in the range of $93,000—$160,000 USD
