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is looking for a few
Aubrey Group is looking for a Quality Engineer responsible for setting and overseeing quality engineering and supplier quality practices that ensure continuous improvement of production processes in line with set standards.
The Quality Engineer will interact with Operations and Engineering on technical issues and solutions, provide technical support to engineering projects and approve engineering documentation, process hardware verification and validation; oversee supplier quality program, and make systematic improvements to the Quality Management System.
Drive the resolution of internal and external quality issues.
Utilize the CAPA system to institute resolutions for product and process issues.
Establish and drive supplier quality program with noted improvements in supplier and product quality. Actively drive supplier quality through SCAR’s and supplier audits.
Provide guidance to engineering teams as required.
Assist with client and regulatory agency audits.
• Bachelor’s degree (B.Eng./B.A./B.S.) from four-year college or university with at least five years relevant experience in Quality Assurance in medical device manufacturing.
• Experience in developing and implementing ISO/FDA compliant quality management systems and supplier quality programs, including purchased part approval programs.
• Past experience in Operations and/or Design Engineering highly desired.
• Possess a working knowledge of Process Controls and Design Controls within a regulated Quality Management System (CFR 820).
• Working knowledge of statistical principles, data collection and utilizing appropriate software tools.
• Ability to initiate, lead, consult, and contribute to corrective and preventative program to improve quality across the company.
Test and troubleshooting electronic medical instrumentation. Working from engineering drawings, schematics, wiring diagrams, or other sources of engineering documentation, perform all operations required to assemble, test and troubleshoot analog and digital engineering breadboards, modify surface-mount printed circuit boards, wire assemblies, and test and troubleshoot completed systems. Maintain engineering lab instrumentation, materials and supplies. Will participate in preparation of test protocols, procedures, and documentation. Will work closely with design engineers.
• Associate Degree in Electronics and at least three years of experience as an R&D electronics technician. Experience in working with surface-mount components and PCBs, schematic reading, and electronics parts is essential. Must be familiar with standard laboratory test equipment including oscilloscopes and logic analyzers and Microsoft Office suite (Word, Excel, Visio).
• Positive attitude, technical aptitude, and willingness to learn will be greatly valued. Virtually unlimited potential for growth – “work flows to the competent”.
We are seeking a Senior Mechanical Design Engineer. The ideal candidate would have experience with mechanisms, fluidics, disposables, electronic packaging, and molded plastics. We also look for adaptability and broad intelligence; a wide range of skills, experience and knowledge; and the ability to balance the competing demands of multiple projects.
Position involves interfacing with other engineering disciplines and interacting with clients. If interested, person may eventually migrate into project management involving writing technical proposals, estimating, planning and scheduling, and running projects.
Requirements: BSME or MSME with minimum 7 years experience. Proficiency in SolidWorks or other solid modeling CAD software. Experience with general design engineering practices, prototyping, engineering documentation, mechanical and electromechanical components. Familiarity with FDA, ISO and IEC design controls desired.