x4 life sciencesBaltimore, MD
Quality Assurance Associate
Quality Assurance Associate
Quality Assurance Associate
x4 life sciencesBaltimore, MD
2 days ago
Quality Control Systems ManagersQuality Control AnalystsInspectors, Testers, Sorters, Samplers, and Weighers
Electromedical and Electrotherapeutic Apparatus ManufacturingSurgical Appliance and Supplies ManufacturingSurgical and Medical Instrument Manufacturing
Apply for this role →QA Associate/Specialist | Medical Devices | MarylandX4 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 reviews Helping manage customer complaints, nonconformances and CAPAs, from investigation through to closure Supporting Health Canada compliance requirements Taking part in internal audits and supplier quality activities Uploading and managing controlled documents in the eQMSReviewing 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 MDSAPExperience handling complaints, nonconformances and CAPAsComfort working onsite in a manufacturing, assembly and test environmentA 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 401kHealthcare coverage 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. Want to find out more? Apply here or contact me directly at o.archer@x 4lifesciences.com.
Also on the board Same function, level within a rung
Level
Lead
Location
Baltimore, MD
Occupation
Quality Control Systems Managers
Industry
Electromedical and Electrotherapeutic Apparatus Manufacturing
Posted
2 days ago