New

USA - Quality Assurance Engineer I- CTQ

Equiliem
United States, New York, Skaneateles
Mar 13, 2025
I. SUMMARY: This description outlines the employment prerequisites and job responsibilities for the position of Engineer, Quality Complaint Investigation. II. ESSENTIAL FUNCTIONS: This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs. Review individual complaints and associated service data to determine risk level and complete investigation into the "as "determined" problem code and cause codes for each complaint. Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues. Prepare and issue reports based on information analysis. Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner. Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions. Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation. Support CAPA and maintenance activities for existing product lines. Recommend and/or support projects for improvements to the quality system as approved by management. III. QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED * Medical Device Experience with knowledge of 21CFR820 preferred. * Investigational research skills * Experience with any statistical software packages (Minitab a plus) * Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods. * Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS (optional). * Knowledge and working application of reading and understanding blueprints and technical drawings. * Demonstrated strong analytical problem solving (Root Cause Investigations. * Display a solid technical understanding of engineering principles and procedures (e.g., CAD and its application or scheduling a series of technical tasks utilizing software-based tools). * Computer competency in Word, Excel, Power Point, Minitab, Access and databases. * Ability to multi-task and methodically manage projects. IV. EDUCATION/EXPERIENCE REQUIRED * A Bachelor of Science degree in Engineering * 1-3 years of Medical Device experience V. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee: * Must be able to sit for long periods of time * Must have good hand to eye coordination and dexterity * Physical Requirements: Dynamic Lifting capability: Must have the ability to lift 40 pounds at a time. VI. WORK ENVIRONMENT Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to: * Wearing a static protective smock at all times while in the work area * Wearing a ground wrist strap and plugging that wrist strap into the working table. * Working in close proximity to other employees. * Working in an environment that is temperature and humidity controlled.