NEW JOB OPENING
VALIDATION ENGINEER
IN Medina, NY, USA!

***Only qualified Validation Engineer candidates located near the Medina, NY area to be considered due to the position requiring an onsite presence***



The client is seeking a Principal Engineer, Quality Validation with a strong background in the medical device industry. The ideal candidate will have 5-8 years of experience implementing and managing quality systems, process controls, and continuous improvement methodologies, along with knowledge of FDA cGMP, ANSI/ISO/ASQC, and CMDAS requirements. They should be skilled in developing and executing validation protocols (IQ, OQ, PQ), managing non-conformance reports, and using formal problem-solving tools for corrective and preventive actions (CAPA). The role requires proficiency in internal auditing, Six Sigma Certification (Green or Black Belt preferred), and the ability to lead, train, and develop team members. The candidate should have strong analytical, project management, and communication skills, with the ability to work both independently and as part of a team in a regulated, technical environment.



EDUCATION/EXPERIENCE:

• Bachelor’s degree in Engineering

• 5-8 years of related experience

• Six Sigma Certification (Green Belt or Black Belt) is desirable



QUALIFICATIONS:

• 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

• 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

• Desired CQE, CSSBB, CQA or initiative to complete certifications

• Prefer experience with TQM methods (e.g. "six sigma")



Validation Engineer Responsibilities:

• 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 assigned

• **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

• **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**