Quality Assurance Specialist

QA Specialist | Medical Devices

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

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

What you'll be doing:

• Supporting the maintenance of the QMS
• Helping with document control and periodic reviews
• Helping manage customer complaints, nonconformances and CAPAs
• Supporting Health Canada compliance requirements
• 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

What they're looking for:

• A solid understanding of QMS principles
• Experience in medical device manufacturing
• Exposure to ISO 13485 (MDSAP is a strong plus)
• Experience handling complaints, nonconformances and CAPAs
• Comfort working onsite in a manufacturing, assembly and test environment

Why this role?

This suits someone with broad medical device 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. They want someone who's happy to roll up their sleeves and get their hands dirty.

Want to find out more? Apply here and contact me directly at View email address on click.appcast.io.