Quality Engineer

H.B. Fuller acquired Adhezion Biomedical, LLC which is a medical device company engaged in the development, manufacturing and commercialization of highly-differentiated, proprietary, cyanoacrylate-based adhesive and infection prevention products.

Quality Engineer that will work with our Operational quality team. This individual will own all quality activities for their assigned product lines and may be working on multiple different products lines at once. They will be assigned to products for new product development and work closely with internal team and Contract Manufacturer on each product. Support Design Engineering and Manufacturing Operations by developing manufacturing processes, work instructions, fixtures, and production equipment.

This individual will be reporting to the Quality Manager for HHC Hygiene Global.

Primary Responsibilities:Manage validation program – IQ,OQ, PQ, & Gage R&Rs.Support projects related to lean manufacturing plant layout, process to ensure efficient and timely completion.Assist with design transfer to manufacturing, including quality control activities from production processes to shipment of the final product.Work with Contract Manufacturer (CM) to review existing process and implement new manufacturing processes.Inspect product including labeling and documentation for release of finished goods.Manage product traceability and labeling.Manage and maintain product device history records.Ensure that all production employees are familiar with, trained on, and follow all manufacturing procedures related to their jobs Ensure that changes to procedures are reviewed, approved and validated prior to implementation.Oversee creation and review of documentation for nonconforming product.Lead product investigation related to customer complaints and corrective actions.Works with Engineering department ensuring that engineering change orders affecting production related changes are reviewed.Assist with revisions and updates to quality procedures, standardized work instructions.Maintain equipment calibration program to ensure equipment is calibrated in a timely manner.Participate in supplier management activities. Identify supplier issues.Assist with APQP and Risk Management Documentation.Support Internal Quality Audit.Support 3rd party audit and inspection activities.Coordinate and Support Weekly Inspection of Facilities, Daily Facility Walks and Bioburden & Particulate Assessment.Identify, Communicate, Drive & Support Resolution of Quality Issues as Identified in the Production Area.Support Sterility Management Program.Support Document Control & Lab Functions.Champion cGMP – General Omnsbudman for Production.

Minimum Requirements:BS degree in manufacturing, mechanical, industrial or process engineering, highly desiredMinimum of 2 years’ experience (5+ years preferred) in manufacturing engineering in a process driven manufacturing environmentHands-on experience troubleshooting equipmentProficient with SolidWorks or equivalent 3D CAD softwareWorking knowledge of Microsoft Office products (Work, Excel, Outlook, PowerPoint)Ability to multi-task and meet deadlines in a fast-paced environmentAbility to communicate effectively and professionally with internal and external partiesAbility to work in a team environment

Physical Environment and Requirements:Standing on concrete floors for several hours at a time.Essential physical requirements, such as climbing, standing, stooping or typing.Lifting up to 30 pounds.Work in loud/chaotic environments.Wear appropriate PPE such as mask, goggles, footwear as applicable.The ability to see and respond to situations.