Quality Assurance Associate

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

QA Associate/Specialist | Medical Devices | Maryland

X4 Life Sciences is partnered with a lean, progressive medical device manufacturer based in Maryland. They have a portfolio of long-established, FDA-cleared products. Production, assembly and testing all happen onsite, and the business keeps high standards of quality and regulatory compliance across the U.S. and Canadian markets, including MDSAP.

It's a small and growing company. That means your work is visible and the people in charge listen to your ideas. You'll work closely with the owner of the business.

They're now hiring a QA Associate/Specialist to support the day-to-day running of their Quality Management System. The role is fully onsite because you'll work closely with production, assembly and testing.

What you'll be doing:

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

What they're looking for:

• 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

What's on offer:

• A salary that is open and very much dependent on the individual
• Bonus
• 401k
• Direct exposure to the leadership team, with the chance to shape how quality is run

Why this role?

This suits someone with broad quality experience who wants variety. You'll work across the whole QA function, not just one part of it. It's a small, growing company, so there's real scope to make an impact and grow with the business. They want someone who's happy to roll up their sleeves and get their hands dirty.