Onsite QA Specialist — Shape Quality & Grow with Leadership

X4 Life Sciences; Maryland; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Bonus

401k

Direct exposure to leadership

Job summary

X4 Life Sciences in Maryland is seeking a QA Specialist to support the day-to-day operation of the Quality Management System on site. You will work closely with production, assembly and testing teams to ensure quality and regulatory compliance across our manufacturing floor.

The role offers hands-on ownership, exposure to CAPAs, complaints, and internal audits within a small, growth-oriented environment. A proactive QA professional will thrive here.

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.
• A proactive, hands-on attitude and a willingness to take ownership.

Responsibilities

• Maintain and improve the QMS.
• Assist with document control and periodic reviews.
• 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

ISO 13485

CAPA handling

Onsite manufacturing

Job description

X4 Life Sciences in Maryland is seeking a QA Specialist to support the day-to-day operation of the Quality Management System on site. You will work closely with production, assembly and testing teams to ensure quality and regulatory compliance across our manufacturing floor.

The role offers hands-on ownership, exposure to CAPAs, complaints, and internal audits within a small, growth-oriented environment. A proactive QA professional will thrive here.