**Come join us and grow your career with CTG! CTG has worked with this international, Fortune 500 end-client for over 15 years! Apply with CTG for this exciting opportunity!** CTG's premier client has a contract assignment for a **Quality Engineer II.** **Type:** Contract **Job Title:** **Quality Engineer II** **Location:** **Remote** **Description** + Support the standardization of quality engineering systems, architecture, and specifications across Division manufacturing facilities + Support actions for streamlined validation processes to ensure conforming, compliant product is made available to customers in a timely manner + Participate in problem solving and root cause analysis activities (e.g. CAPAs, SCARs) internally and with suppliers and customers to eliminate recurrence of nonconformances and ensure continuity of supply + Conduct supplier audits as needed to meet requirements + Support actions to drive process standardization, waste elimination, and continuous improvement with suppliers + Conduct division/customer/3rd party audits of internal sites as required + Actively support new product launches for products manufactured by Corning or 3rd party manufactured product for Corning which would include Supplier Selection and Qualification and Product Validation. + Leveraging quality engineering best practices, champion and use standard product life cycle management systems, tools, and outputs: + Design & Development Controls + Product Verification & Validation + Process and Equipment Validation (e.g. IQ/OQ/PQ) + Product Quality Architecture (PQA) + Innovation + Manufacturing Innovation Excellence (MIE) + Manufacturing Scalability Playbook (MSP) + Other Performance Excellence (PEx) tools as appropriate (e.g. Six Sigma tools, FMEA, DoE, Measurement System Analyses, Gauge Repeatability & Reproducibility (R&R), DMAIC, Manufacturing Engineering Excellence (MEE), Lean, etc.) + Supplier Performance and Quality Management + Lead Quality projects of small scale and complexity + Participate in and sometimes lead Quality lead on projects of moderate scale and complexity + Supporting Quality lead on projects of sizable scale and complexity + Proficient on industry-relevant customer expectations (e.g. sterility, leachables/extractables, in vitro and in vivo toxicity, biological and chemical contamination sources and mitigation, etc.) + Support in the creation of technical documentation that fits business needs and maintains compliance to applicable international standard and regulatory requirements (e.g. ISO, FDA, EU, etc.) + Author Design History Files, customer-facing validation guides, change notifications/validation summaries, product certifications, and instructions for use literature + Some travel is required as part of the job responsibilities. **Qualifications** **Education:** + BS Degree in an engineering, scientific, or statistical field + Minimum of 3 years of manufacturing quality or related engineering experience. + 0-2 years of experience in validation application. + In depth knowledge of applicable and similar industry requirements (e.g. ISO 9001, ISO 13485, ISO 15378 Quality Systems Regulations 21 CFR part 820, EU IVDR and MDR) + Knowledge of manufacturing processes and relevant statistical methods for quality assurance. **Qualifications:** + Capable of the integration and application of user targeted manufacturing process documentation while meeting business and regulatory requirements. + Good understanding of Continuous Improvement/PEx Methodologies, including lean, six sigma, statistical applications and validation. + Working knowledge of relevant software for data collection (e.g. ERP, PI, eQMS), data storage and analysis (e.g. Microsoft Access, Microsoft Excel), project management (e.g. Microsoft Project), statistics (e.g. R, Minitab, JMP), word processing (e.g. Microsoft Word), reporting (e.g. Microsoft Visio, Mindjet MindManager, Microsoft PowerPoint), and communication (e.g. Microsoft Outlook, Microsoft Skype, Microsoft Teams, Microsoft SharePoint, Cisco WebEx). + Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams. + Ability to influence individuals without authority and to motivate others within a project team. + Ability to make data-derived decisions regarding product and process suitability and conformance. + Must be an effective communicator (written and verbal), highly organized, motivated, detail oriented with excellent analytical thinking and problem-solving skills. + Ability to lead projects and coordinate the efforts of others to complete project goals; must also possess the ability to effectively manage conflict. + Ability to lead change management and perform other duties as assigned. **Preferred:** + Life Science or Pharmaceutical Packaging product application knowledge and experience. + Certified Quality Engineer recognition by ASQ. + Green or Black Belt **Additional Information** + No third party resumes will be accepted + Drug testing and/or other employment-related inquiries may be conducted + CTG will consider for employment-qualified applicants with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws. + All interested individuals **MUST be able to work on a W2 Tax basis (no C2C or third party vendors)** + CTG is an Equal Employment Opportunity employer + CTG is an E-Verify Company **To Apply** To be considered, please apply directly to this requisition using the link provided. For additional information, please contact **Laura Dominguez** at **716-887-7203** or **laura.dominguez@ctg.com** . Kindly forward this to any other interested parties—thank you! The expected base salary for this position ranges from $49 to $51 hourly. Salary offers are based on a wide range of factors including relevant skills, training, experience, education, market factors, and where applicable, licensure or certifications obtained. In addition to salary, a competitive benefit package is also offered. **About CTG** CTG, a Cegeka company, is at the forefront of digital transformation, providing IT and business solutions that accelerate project momentum and deliver desired value. Over nearly 60 years, we have earned a reputation as a faster and more reliable, results-driven partner. Our vision is to be an indispensable partner to our clients and the preferred career destination for digital and technology experts. CTG leverages the expertise of over 9,000 team members in 19 countries to provide innovative solutions. Together, we operate across the Americas, Europe, and India, working in close cooperation with over 3,000 clients in many of today's highest-growth industries. For more information, visit www.ctg.com . Our culture is a direct result of the people who work at CTG, the values we hold, and the actions we take. In other words, our people define our culture. It's a living, breathing thing that is renewed every day through the ways we engage with each other, our clients, and our communities. Part of our mission is to cultivate a workplace that attracts and develops the best people, reflected by our recognition as a Great Place to Work Certified™ company across many of our global operations. CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws. CTG is an Equal Opportunity and Affirmative Action Employer. CTG will assure equal opportunity and consideration to all applicants and employees in recruitment, selection, placement, training, benefits, compensation, promotion, transfer, and release of individuals without regard to race, creed, religion, color, national origin, sex, sexual orientation, gender identity and gender expression, age, disability, marital or veteran status, citizenship status, or any other discriminatory factors as required by law. Our Affirmative Action program serves to promote occupational equality and diversity through good faith efforts. CTG is fully committed to promoting employment opportunities for members of protected classes.