Quality Assurance Associate

QA Associate/Specialist | Medical Devices | MarylandWhile professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.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 QMSHelping with document control and periodic reviewsHelping manage customer complaints, nonconformances and CAPAs, from investigation through to closureSupporting Health Canada compliance requirementsTaking part in internal audits and supplier quality activitiesUploading and managing controlled documents in the eQMSReviewing production documentation for accuracy and completenessHelping update SOPs and general quality documentationWorking with production, assembly and test teams to resolve quality issues on the floorWhat they're looking for:A solid understanding of QMS principlesExperience in a life sciences environment (medical device experience preferred)Exposure to ISO 13485 or MDSAPExperience handling complaints, nonconformances and CAPAsComfort working onsite in a manufacturing, assembly and test environmentA proactive, hands-on attitude and a willingness to take ownershipWhat's on offer:A salary that is open and very much dependent on the individualBonus401kHealthcare coverageDirect exposure to the leadership team, with the chance to shape how quality is runWhy 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. xhyhwjd Want to find out more? Apply here or contact me directly at