Quality Validation Engineer - Equipment Validation

Nemera•Buffalo Grove, IL

2d•$85,000 - $105,000•Onsite

About The Position

The Quality Validation Engineer plans, coordinates, and manages assigned projects through completion to ensure product development and production meet customer and internal quality deliverables. The role coordinates and leads customer complaint investigations and works with Supply Chain management to evaluate and manage supplier performance. Duties are performed individually or in collaboration with other staff. The position supports the Quality Manager in achieving company objectives and improving product quality and operating-system efficiency while minimizing costs. It manages validation and change-control activities, assesses complaint investigations and corrective actions for regulatory and standards compliance, and applies statistical and problem-solving methods to reduce failures and improve quality. The engineer also develops and reviews product specifications, evaluates supplier quality, supports supplier quality agreements, and trains internal departments on quality topics. The role interacts with customers and suppliers to align on requirements, supports customer audits and resolution of findings, and helps maintain ISO and FDA QSR quality systems. It also carries out responsibilities under the company quality operating system, supports applicable quality, health and safety, and continuous-improvement policies, and completes improvement projects using Six Sigma tools and methodologies. The work takes place in a clean manufacturing environment and includes up to 25% travel, some of which may be international.

Requirements

Bachelor’s degree in Engineering, Science, or a related field.
Three or more years of experience in a Quality position is strongly preferred.
Excellent English communication skills, including the ability to understand, read, write, and speak English.
Ability to apply advanced mathematical concepts and intermediate statistical knowledge, including SPC.
Intermediate computer skills, including Microsoft Office applications.
Ability to work independently from verbal and/or written instructions.
Ability to understand and articulate how the individual role and responsibilities relate to Quality department functions, goals, and objectives.
Ability to regularly lift up to 30 pounds with repetitive movements, push and pull items, and stand, sit, or walk for up to 80% of a shift.
Ability to travel between office and production departments as well as company buildings.
Up to 25% travel required, including some international travel.

Nice To Haves

Medical Device industry experience, particularly with ISO 13485, is strongly preferred.
Technical writing and IQ/OQ/PQ experience is preferred.
Equipment validation experience is preferred.
Experience working onsite in Manufacturing is strongly preferred.
Six Sigma experience, training, or certification is preferred.
SAP experience is preferred.

Responsibilities

Assist the Quality Manager in coordinating and executing company objectives with other departments to maximize product quality and operating-system efficiency and effectiveness while minimizing cost.
Identify and coordinate resolution of system inefficiencies that contribute to increased quality costs.
Coordinate and manage validation execution and creation of written protocols.
Coordinate and manage change-control activities.
Assess customer complaint investigations and corrective actions for application, validity, and compliance with FDA regulatory, QSR, ISO, and customer requirements.
Use CAPA problem-solving techniques and methods such as FMEA, Design of Experiments, Cause and Effect, Flow Charts, and SPC to address problems and assess outcomes against specifications.
Develop and analyze statistical data related to assigned tasks to evaluate current standards and propose quality improvements, including analysis of inspection methods and sample plans.
Evaluate whether events or processes comply with specifications, operating procedures, or standards using relevant information and individual judgment.
Develop product specifications for existing products and assess existing specifications for accuracy and compliance.
Plan, coordinate, and manage assigned Supplier Quality evaluations, including supplier scheduling and audits.
Interact with suppliers to ensure mutual understanding of specified requirements and fulfillment of customer requirements and objectives.
Support implementation and management of quality agreements with assigned suppliers.
Plan, promote, perform, and organize internal training on quality activities, including basic statistics, DOE, GR&R, and sample plan designation.
Interact with customers to ensure mutual understanding of specified requirements and fulfillment of customer requirements and objectives.
Assist Quality Managers during customer audits and lead findings and observations through final resolution.
Assist in maintaining ISO and FDA QSR quality-system compliance.
Execute assigned responsibilities defined within the company quality operating system.
Support company policies, including applicable FDA regulatory and ISO requirements, health and safety requirements, and continuous-improvement initiatives.
Identify and complete continuous-improvement projects using Six Sigma tools and methodologies.
Perform other duties as assigned.