Quality Engineer/ Medical Device
Peachtree City, GA | Direct Hire
Our customer in the Peachtree City, GA area, a medical device manufacturer, is currently looking for a Quality Engineer to join their team on a long term, direct hire basis.
Quality Engineer will be responsible for the quality/validation support of production injection molding and assembly. Work cross-functionally to lead validation of new products and ensures efficient and effective transfer of validated processes and assets into production.
• Provide Validation input (DOE, FAT, SAT, DQ, IQ, OQ, PQ) to cross-functional teams involving R&D, Marketing, Regulatory, developing medical devices.
• Support line transfers, qualification and verification activities at site
• Support supplier selection activities, address quality issues as they arise
• Develop statistically relevant test methods, protocols and documentation to support manufacturing of medical devices.
• Conduct technical reviews; ensure documentation is available to meet Quality Systems Requirements. (BOMs, Gage R&R, FMEAs, etc.).
• Actively participates in concept review and development on new injection-molded products.
• Support various teams and work closely with Project Management to smoothly transition new products to production. Provide frequent and appropriate communications with all internal customers
• Stay current on core competencies and best practices in manufacturing to ensure incorporation into new qualifications / validations.
• Identify root cause and implements corrective and preventive measures to improve or ensure product quality across product lines.
• Ensure product documentation and manufacturing processes meet all Quality system requirements.
• Designs, installs, and continually evaluate quality assurance and/or control methods and Systems.
• Conduct statistical analysis in the form of capability studies to evaluate processes.
• Develop standards, procedures, and work instructions.
• Apply in-depth knowledge of statistical techniques, with ability to identify, analyze and define possible solutions for continuous product and process improvement
• Develop sampling plans and statistical methods to be utilized by manufacturing and inspection to include determination of control points and charting methods.
• Interface with engineering and CMM programmers to validate fixtures and processes to ensure the effectiveness of measurement systems.
• Conduct internal and external audits and supplier surveys to verify capability and/or compliance.
• Coordinate and participate in material review activities to determine nonconforming product dispositions and corrective actions.
• Plan, conduct and take action regarding gauge R&R, product and process capability studies.
• Occasional travel to offshore locations may be required up to 25%.
• 4 year Engineering Degree or equivalent experience.
• Minimum of 5 years of experience in the areas of quality management in the medical device field preferably
• invasive, single use medical devices. Ideally validation experience in the product or process development of plastic components and assemblies.
• Ability to apply engineering principles to an idea or set of user requirements -- and then convert this into the regulatory requirements for a device or combination product.
• Ability to develop injection molding and assembly Validation Master Plans.
• Experience in plastics testing – particularly ASTM and ISO mechanical tests.
• Ability to make data-based and risk-based decisions to drive projects efficiently.
• Good understanding of Design for Manufacturability principals, GAMP5, UL and EU electrical standards.
• Expertise of FDA regulations and validation of automation equipment, i.E. SAT, FAT, IQ, OQ, PQ.
• Proficient with Microsoft Project, Minitab, and very proficient in Microsoft Office products.
• Ability to communicate vertically and horizontally through multiple channels to motivate diverse teams, and enable cross-functional collaboration.
• Authoritative command of complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analyses and influence decision-making.
Submit resume to heather.Moore@trcstaffing.Com