Quality Assurance Associate

About the Role

X4 Life Sciences is partnered with a lean, progressive medical device manufacturer based in Maryland. The company has a portfolio of long-established, FDA-cleared products. Production, assembly, and testing all happen onsite. The business maintains high standards of quality and regulatory compliance across the U.S. and Canadian markets, including MDSAP. This is a small and growing company where your work is visible, and your ideas are heard. You will work closely with the owner of the business. They are hiring a QA Associate/Specialist to support the day-to-day running of their Quality Management System (QMS). The role is fully onsite to facilitate close collaboration with production, assembly, and testing teams.

Key Responsibilities

• Supporting the maintenance and improvement of the QMS
• Assisting with document control and periodic reviews
• Helping to manage customer complaints, nonconformances, and CAPAs from investigation through to closure
• Supporting Health Canada compliance requirements
• Participating in internal audits and supplier quality activities
• Uploading and managing controlled documents in the eQMS
• Reviewing production documentation for accuracy and completeness
• Assisting in updating SOPs and general quality documentation
• Collaborating with production, assembly, and test teams to resolve quality issues on the floor

Requirements & Tech Stack

• A solid understanding of QMS principles
• Experience in a life sciences environment (medical device experience preferred)
• Exposure to ISO 13485 or MDSAP
• Experience handling complaints, nonconformances, and CAPAs
• Comfort working onsite in a manufacturing, assembly, and test environment
• A proactive, hands-on attitude and a willingness to take ownership
• Broad quality experience with a desire for variety across the QA function.

Qualifications

• None explicitly stated beyond the requirements listed above.