Quality Validation Engineer - Equipment Validation

Nemera•Buffalo Grove, IL

1d•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 may be performed independently or in collaboration with other staff. The position assists the Quality Manager with company-wide quality objectives and operating-system effectiveness. It manages validations, written protocols, and change control; assesses complaint investigations and corrective actions for regulatory and customer compliance; uses CAPA and other problem-solving methods; analyzes statistical data and inspection methods; and evaluates processes against specifications and standards. It also develops and reviews product specifications, conducts supplier evaluations and audits, supports supplier quality agreements, and provides quality-related training. The engineer works with customers and suppliers to clarify requirements, supports customer audits and resolution of findings, and assists with maintaining ISO and FDA QSR quality-system compliance. The role also supports company policies, health and safety requirements, continuous improvement initiatives, and other assigned duties. The work is performed in a clean manufacturing environment that may have moderate noise and requires appropriate PPE and cleanroom apparel. The role involves regular lifting, pushing and pulling items, and standing, sitting, and walking for up to 80% of a shift. Travel between office and production departments and company buildings is required, as is up to 25% travel, including some international travel.

Requirements

Bachelor’s degree in Engineering, Science, or a related field.
Excellent communication skills and 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 explain how individual responsibilities relate to the Quality department’s function, goals, and objectives.
Ability to regularly lift up to 30 lbs with repetitive movements; push and pull items; and stand, sit, and walk for up to 80% of a shift.
Ability to travel between office and production departments and company buildings.
Ability to travel up to 25%, including some international travel.

Nice To Haves

At least 3 years of experience in a Quality position.
Experience in the medical device industry, especially ISO 13485.
Experience with technical writing and IQ/OQ/PQ.
Experience with equipment validation.
Experience working onsite in manufacturing.
Six Sigma experience, training, or certification.
SAP experience.

Responsibilities

Assist the Quality Manager in coordinating and executing company quality objectives with other departments.
Identify and coordinate resolution of system inefficiencies that contribute to increased quality costs.
Coordinate and manage validations and the creation of written protocols.
Coordinate and manage change control activities.
Assess customer complaint investigations and corrective actions for applicability, validity, and conformance to FDA regulatory, QSR, ISO, and customer requirements.
Use CAPA problem-solving techniques and select appropriate tools, including FMEA, Design of Experiments, Cause and Effect, Flow Charts, and SPC, to address problems and assess results.
Develop and analyze statistical data, assess current standards, and establish proposed quality improvements, including reviewing inspection methods and sample plans.
Evaluate whether events and processes comply with specifications, operating procedures, or standards.
Develop specifications for existing products and assess existing specifications for accuracy and compliance.
Plan, coordinate, and manage supplier quality evaluations, including scheduling and auditing suppliers.
Work with suppliers to ensure mutual interpretation of requirements and achievement of customer requirements and objectives.
Support implementation and management of quality agreements with assigned suppliers.
Plan, promote, organize, and conduct quality training for internal departments, including training related to basic statistics, DOE, GR&R, and sample plan designation.
Interact with customers to clarify requirements and help ensure customer objectives are met.
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 responsibilities defined in the company quality operating system and support applicable company, regulatory, health and safety, and continuous improvement policies.
Identify and complete continuous improvement projects using Six Sigma tools and methodologies.
Perform other duties as assigned.