QC Technician

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About Instylla:

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.

Position Summary/Role and Responsibilities:

The QC Technician is responsible for following established procedures and methods to perform product and process inspections.

• Perform in-process inspections and lot release to support the manufacturing process.
• Facilitate incoming inspections and the receiving process by performing testing, inspections, and verifying required documents and information are on file.
• Work with cross-functional teams and supervisor to determine and follow prioritization of tasks based on production needs.
• Support the quality system by maintaining thorough and complete documentation, adhering to GDP practices.
• Organize and maintain quality lab and functional spaces.
• Perform other testing or quality related tasks when requested.

Qualifications & Education Requirements:

• 0-2 years of quality experience in medical device or related industry.

Knowledge/Skills:

• Ability to operate laboratory instruments such as balances, pipettes, etc.
• Excellent hand/eye coordination and the ability to see fine details by eye and under magnification.
• Attention to detail needed to execute procedures, perform product inspections, accurately complete documented records, and ensure compliance to SOPs and other documented practices.
• Must be able to multi-task, meet established deadlines, and work with supervisor to prioritize changing demands.
• Ability to work independently or with teams.
• Takes responsibility for assignments. Must be self-motivated and possess good organizational skills.
• Commitment to quality and safety.
• Must have clear and legible handwriting.
• Strong communication skills.

Preferred Skills:

• Experience working in a lab and/or cleanroom environment.
• Experience performing mechanical testing.

Working Conditions:

• General office/lab environment and clean room environment.
• Ability to lift up to 25lbs.
• Ability to stand for a minimum of 3+ hours.