Quality Engineer

Quality Engineer

Our client provides coatings that are applied to a variety of metals – including stainless steel, nitinol and silver-plated copper – and used in numerous applications like mandrels, pull wires, core wires, hypotubes, stylets and guidewires. They are committed to providing their customers with market-leading coated mandrels, wire and lubricious products that enable the manufacturing of innovative life-saving devices. Take advantage of this opportunity with an incredibly stable company that is growing before someone else does!

The Quality Engineer is responsible for supporting the effectiveness of the Quality Management System (QMS) and to ensure compliance of QMS activities to ISO13485:2016. Partner with management team to ensure adherence to the QMS. Provide consistent product and process support for shop floor manufacturing to ensure maximized uptime and high product quality is achieved.

• Support and maintain the Quality Management System (QMS) to ensure its continued suitability, adequacy, effectiveness, and alignment with business objectives and KPI improvements.
• Provide shop floor quality support by troubleshooting issues, conducting root cause analysis, participating in Red Cart and Gemba Walk activities, and partnering with Engineering to maximize production uptime.
• Own and manage the Corrective and Preventive Action (CAPA) and Nonconforming Material (NCMR) systems, including leading the Material Review Board (MRB) process where applicable.
• Support equipment qualification and validation activities (IQ, OQ, PQ, etc.) by collaborating with Engineering to develop and execute validation protocols.
• Perform quality assurance activities including First Article Inspections (FAI), product quality inspections, Measurement System Analysis (Gage R&R) where applicable, and measuring and monitoring equipment calibration as needed.
• Develop, revise, and maintain quality documentation, including Standard Operating Procedures (SOPs), Work Instructions, Forms, and provide input to FMEAs and risk management activities.
• Support supplier quality by participating in Approved Supplier List (ASL) evaluations, reporting, and supplier feedback, while providing training as required.
• Perform other quality-related duties and responsibilities as assigned by the supervisor.

• 3 to 5 years experience in quality engineering in medical device or medical components industry
• Full understanding of a QMS and conformance to ISO13485:2016 Nonconforming materials, calibration, corrective and preventive actions, root cause analysis, etc.
• Experience in medical component or medical device manufacturing required.
• Proficient in use of metrology (hand devices, vision systems, microscopes, non-contact devices, profilometer).
• Basic proficiency in reading drawings, GD&T and blueprints.
• Experience in customer, registrar or FDA audits/inspections a plus.
• Ability to navigate a computer ERP system, in certain modules, and perform data entry, data retrieval.
• Computer Skills – Microsoft Office Suite: Word, Excel, Powerpoint, Visio required (QMS software and Minitab experience a plus).

Bachelor's Degree in related field

• 401K: Eligible after 3 months, automatically enrolled at 6%, match 3%, and Profit Sharing
• Tufts Medical / Delta Dental / EyeMed Vision – all eligible after 30 days