Sr. Quality Engineer

Client: Medical Device Company Employment Type: Contract on W2 (Need US Citizens or GC Holders Only) No H1B’s This position performs various quality-engineering functions and support tasks in developing knowledge and experience in Supplier Quality Assurance/Document Control. It primarily supports V. Mueller Platform Quality in addressing gaps in product specifications for purchased materials and supports the Quality System, Design Control System, Document Control, Manufacturing, and R&D/Product Development departments. Job Title Sr. Quality Engineer Location Vernon Hills, IL Duration 5+ Months Essential Duties and Responsibilities Performs gap assessments pertaining to purchased materials specification. Creates and revises current product specifications via Change Control and Project Plans. Creates and reviews protocols, process and product validations. Creates and reviews test methods and addresses test method validation. Creates and reviews documents required for Design History File. Creates and reviews risk assessments such as FMEA, FMECA or FTA. Ensures compliance to V. Mueller Quality Department and BDI- Surgery policies and procedures. Participates and has membership in trade and/or professional organizations to ensure state‑of‑the‑art industry standards are communicated into the division efficiently. Interfaces with V. Mueller manufacturing facilities or other Division facilities. Supports root cause investigations and other steps of the CAPA process. Travels as required by the above duties and responsibilities. Qualifications Ability to perform detailed engineering work under the direction of a Senior Engineer or Quality Management. Understands basic applied GD&T concepts, metrology, typical supplier management processes, and engineering drawing conventions. Ability to participate in teams and maintain a positive work environment. Good communication skills (verbal, written, and presentation). Understands basic fundamentals of engineering principles. Ability to effectively manage time and handle multiple task assignments. Ability to translate quality requirements into product specifications. Ability to interpret regulations, corporate, division, and department procedures. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience BS in Engineering, Engineering Technology, or Science. American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred. Minimum 3 years of experience in FDA‑regulated industry, preferably managing supplier relationships/specification management. #J-18808-Ljbffr