Quality Assurance Engineer

Quality Assurance EngineerSkaneateles, NY | On-siteSince 1973, Tessy Plastics has been a global leader in injection molding and custom automated assembly solutions, partnering with top brands across the Medical, Pharmaceutical, Diagnostics, Consumer Healthcare, and Consumer markets. With 3.2M+ sq. ft. of FDA/GMP-compliant facilities and operations in the U.S. and China, we turn complex ideas into high-performance manufacturing solutions – and we're just as proud to be a great place to build a career!Position OverviewThe Quality Assurance Engineer will support quality related issues within operations. They work collaboratively with the Certified Floor Auditor Level IIIs and the Quality Layout Technicians as well as members of the Production and Customer Service teams to ensure that all quality standards are met. Formulate lean six sigma practices to address continuous improvement in order to prevent nonconformance and ensure that end products meet and/or exceed customer specifications and company objectives are met.What You'll DoLeads continuous improvement efforts within the manufacturing cell.Analyzes data to determine appropriate root cause and corrective actions needed.Supports Audits (Regulatory or Customer) interface within the assigned customer or manufacturing cell.Lead root cause investigations and implement corrective & preventive actions (CAPA).Support validation activities, including IQ/OQ/PQ, as required.Develop strategies and use tools to manage multiple customer specific projects to meet key metrics of on time delivery and overall product quality.Verifies that all appropriate instructions are in place to meet customer, FDA and/or other outside agencies requirements.What You BringBachelor's Degree in relevant field of study preferred or equivalent 5+ years' experience in Quality Engineering.Knowledge of quality systems, standards, and regulatory requirements (FDA/GMP preferred).Possess attention for detail with a high degree of accuracy.Advanced computer experience/proficiency.Ability to read and interpret documents such as contracts, quality agreements, standards.Must apply Statistical, Graphical and practical understanding to carry out instructions furnished in written, oral, or diagram form.Ability to multitask and problem solve involving several variables in working situations.Proficient in use of statistical tools and have a strong understanding of Statistical Process Control methodology to the quality assurance process.Experience in injection molding, automation, or regulated industries preferred.Six-sigma experience Black belt desired.Compensation & BenefitsSalary Range: $80,000 - $100,000Health, Dental & Vision Insurance: 100% employer-paid for employee-only coverage, +1 and Family coverage options available.Additional Incentives: Quarterly profit-sharing program.401K Company match.Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.Tessy Plastics Corp. is an equal opportunity employer. Tessy evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.