Our client leading medical device industry is seeking a Validation Engineer to join their team. As a Validation Engineer you will be part of the team .The ideal candidate will have experiece in medical device industry in development and deployment of Quality Systems, implementing process controls, and continuous improvement methodologiesTitle: Principal Engineer - Quality ValidationLocation: Medina, NY. ONSITE.Duration: 3 months with the possibility of extension/conversionESSENTIAL FUNCTIONS:The person in this role has primary responsibility for driving overall quality performance, improvement, and compliance throughout the organization. Provide metric reports to management during management reviews and reports. Implement quality programs and establish quality assurance measures at all key stages of manufacturing. Review of manufacturing, purchasing and test documentation to ensure requirements are fulfilled. Review drawings, specifications, procedures, test procedures, inspection and test analysis. Develop procedures for production testing and standardize inspection methods. Promote and train personnel to ensure awareness of regulatory and customer requirements throughout the company. Act as a technical team leader including training and developing less senior staff on the team. Support operations with quality issues/root cause analysis/corrective actions. Support the Quality Management System Lead the development and execution of engineering studies, quality plans, validation packages, and Lead the development and execution of IQ, OQ and PQ protocols for product, processes and equipment within the facility. Write reports summarizing results and statistics for all equipment, product, or process validation projects. Trend and report on the Manufacturing NCRs – including process effectiveness and corrective and preventative actions and make recommendations for improvements. Develop and communicates expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products. Participate as an active member in the new products development team. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures. Conduct or lead corrective and preventive actions in manufacturing using formal problem solving tools and documentation. Provide day-to-day support to engineering and manufacturing in implementing process improvement. Assist or lead process improvement projects (scrap reduction, defect reduction, etc.) Be able to assist, present, defend and communicate with internal and external auditors. Perform other duties as assignedQUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED Experience in the medical device industry in development and deployment of Quality Systems, implementing process controls, and continuous improvement methodologies Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC; CMDAS requirements. Knowledge and working application of validation principles and guidelines and industry practice. Knowledge and working application of PFMEA and Risk Analysis. Knowledge and working application of reading and understanding blue prints and technical drawings. Knowledge and working application of standard operating procedures. 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. Understand and articulate how own role ties within function or discipline Demonstration application of engineering principles on individual/small projects Demonstrated strong analytical problem solving (CAPA), teaming and communications/interpersonal. Desired CQE, CSSBB, CQA or initiative to complete certifications. Prefer experience with TQM methods (e.g. "six sigma"). Internal Quality System auditing experience (ISO 13485 and FDA 21CFR820). Computer competency in Word, Excel, Power Point, Minitab, Access and databases. Ability to multi-task and methodically manage projects. Ability to work independently and in team environments.EDUCATION/EXPERIENCE REQUIRED Bachelor’s degree in Engineering 5-8 years of related experience Six Sigma Certification (Green Belt or Black Belt) is desirablePHYSICAL DEMANDSThe 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: Ability to stand or walk for long periods, lift and carry at least 20 pounds, perform repetitive motions with hands/fingers. Must have good hand to eye coordination and dexterityWORK ENVIRONMENTWork 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. Wear a static protective smock at all times while in the manufacturing work area. Work in close proximity to other employees. Work in an environment that is temperature and humidity controlled.If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson WellsManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.
