QA Associate | Medical Devices – Onsite, Grow with Leadership

X4 Life Sciences; Washington (District of Columbia); On-site; USD 65,000 - 105,000; Full time

Benefits offered by this job

Bonus

401k

Leadership exposure

Job summary

X4 Life Sciences in Maryland is seeking a QA Associate/Specialist to support day-to-day operations of the Quality Management System. The role is fully onsite, working closely with production, assembly and testing teams to ensure regulatory compliance across U.S. and Canadian markets.

You will help maintain and improve the QMS, manage document control, and participate in internal audits, supplier quality activities and CAPAs, driving quality improvements on the factory floor.

Qualifications

• 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.
• Proactive, hands-on attitude and willingness to take ownership.

Responsibilities

• Support maintenance and improvement of the QMS.
• Assist with document control and periodic reviews.
• Help manage customer complaints, nonconformances and CAPAs from investigation to closure.
• Participate in internal audits and supplier quality activities.
• Upload and manage controlled documents in the eQMS.
• Review production documentation for accuracy and completeness.
• Update SOPs and general quality documentation.
• Collaborate with production, assembly and test teams to resolve quality issues on the floor.

Skills

QMS principles

Life sciences environment

ISO 13485 / MDSAP

Complaints / CAPAs

Onsite manufacturing

Ownership mindset

Job description

X4 Life Sciences in Maryland is seeking a QA Associate/Specialist to support day-to-day operations of the Quality Management System. The role is fully onsite, working closely with production, assembly and testing teams to ensure regulatory compliance across U.S. and Canadian markets.

You will help maintain and improve the QMS, manage document control, and participate in internal audits, supplier quality activities and CAPAs, driving quality improvements on the factory floor.