Our customer in the Peachtree City, GA area is looking for a Quality Engineer to join their team on a long term, direct hire basis.
Quality Engineers 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.
Requirements: Education, Experience
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 minimally 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.
Responsibilities: Roles, Tasks
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.