Medical Device Quality Control Analyst

Job Description

Job DescriptionQuality Control Analyst: Elevating Standards in Medical Devices

In this pivotal role, you will be at the heart of ensuring the integrity of our medical device production. Dive into the dynamic world of manufacturing and packaging, safeguarding our commitment to GMP standards and stringent regulatory guidelines.

What You'll Do

• Play a critical role in the Quality Department by focusing on:
• Raw Materials Inspection—ensure inputs meet our stringent requirements.
• In-Process Quality Checks—monitor ongoing manufacturing processes for compliance.
• Final Product Assurance—review documentation and packaging for a flawless finish.

Function from the Madison Manufacturing documentation nerve center, meticulously archiving your efforts while maintaining pristine quality labels.

Your Collaborations

Operate under the guidance of the Quality Control Manager while teaming up with multi-disciplinary teams—manufacturing, engineering, and more—to address nonconformities and enhance supplier quality.

Desired Profile

• Completed a High School Diploma or its equivalent.
• Preference for those with experience in a regulatory compliance setting.
• Familiarity with FDA regulations and ISO13485 for medical devices.
• The ability to work solo with high motivation and keen attention to detail.
• Capable of effectively using computer systems every day.
• A team player who excels in communication.

Work Environment

Experience the unique setting of our manufacturing facilities, which adhere to controlled environmental standards.

Tools of the Trade

• Proficiency with ISO 13485
• Be adept with calipers and micrometers