Quality Engineer II

Instylla•Bedford, MA

24d•$77,000 - $120,000•Onsite

About The Position

Instylla, Inc. is a privately held medical device company based in Bedford, MA, focused on developing novel resorbable embolic agents to advance interventional radiology, with initial clinical applications in interventional oncology. Instylla was founded in 2017 by Incept LLC and is funded by several leading venture capital groups. The company’s flagship product, Embrace™ Hydrogel Embolic System, is FDA-approved for hypervascular tumor embolization and offers controlled, targeted, and persistent embolization. The Quality Engineer II ensures that the processes needed for the quality management system are established, implemented and maintained per applicable industry standards. Monitor and report on quality systems and programs. Represent quality on cross-functional project teams.

Requirements

Bachelor's degree in scientific/engineering or relevant discipline.
2+ years medical industry experience in a quality function.
Understanding of FDA, ISO 13485, and EU MDR requirements.
Knowledgeable in application of quality principles and industry guidelines for quality systems.
Solid technical background and scientific judgement.
Strong critical thinking, root cause analysis, and problem-solving skills.
Strong communication skills.
Excellent interpersonal skills.
Quality orientation and high attention to detail.
Able to work independently with minimal supervision (self-motivated once given direction/guidance).
Computer literacy, proficiency in MS applications.
Willingness to learn, enthusiasm for continuous improvement.

Nice To Haves

Certified Quality Auditor

Responsibilities

Support Quality Management System implementation and ensure compliance with applicable standards and regulations, including cGMP, CMDR, ISO 13485, EU MDR.
Maintain and support the Supplier Assurance / Supplier Quality program.
Maintain and manage quality subsystems as needed.
Coordinate and lead internal and supplier quality audits.
Support activities related to product verification and validation processes.
Lead or support the Risk Management program and Post Market Surveillance programs.
Work with cross-functional teams to support and/or lead sustaining engineering projects.
Support sterility and biological testing and validation.
Support CAPA activities, including root cause analysis and corrective actions.
Support complaint handling and investigations in accordance with regulatory requirements.
Perform other quality engineering duties when requested.