Equipment Validation Engineer - Quality

Job Description

Job Description

Equipment Validation Engineer – Quality

Buffalo Grove, IL - Onsite

Direct Hire, Fulltime position

Salary Yearly Pay Range: $90,000 - $110,000

We are seeking a highly motivated and experienced Equipment Validation Engineer - Quality to join the team at one of our pharmaceutical manufacturing clients located in Buffalo Grove, IL. In this role, the Quality Validation Engineer is responsible for planning, coordinating, and managing assigned projects to completion, ensuring that the development and production of products meet customer and internal quality deliverables. Coordinate and lead investigations regarding customer complaints. Work with Supply Chain management to evaluate and manage supplier performance. Duties and responsibilities are accomplished personally or through collaboration with other staff.

​ Key Responsibilities:

· Assists the Quality Manager in coordinating and executing objectives throughout the company in cooperation with other departments, to maximize product quality and operating system efficiency/effectiveness while minimizing cost

· Identify and coordinate the resolution of system inefficiencies that contribute to increased quality costs.

· Coordinate and manage the execution of validations and creation of written protocols.

· Coordinate and manage the execution of change control activities.

· Assess results of Customer Complaint investigations and Corrective Actions for application, validity, and conformance to FDA regulatory, QSR, ISO, and Customer requirements.

· Utilize CAPA problem-solving techniques to reduce internal and external failures, select sound techniques (FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC) to solve problems effectively, and assess results for application, validity, and conformance to specifications.

· Develop and analyze statistical data in relation to assigned tasks to determine the adequacy of present standards and establish proposed quality improvements, including analysis of current inspection methods and sample plans.

· Evaluate compliance using relevant information and individual judgment to determine whether events or processes comply with specifications, operating procedures, or standards.

· Develop product specifications for existing products and assess existing specifications for accuracy and compliance.

· Plan, coordinate, and manage assigned Supplier Quality evaluations through scheduling and auditing of suppliers.

· Interact with suppliers and ensure mutual interpretation of specified requirements to make certain customer requirements and objectives are met.

· Support implementation and management of quality agreements with assigned suppliers.

· Plan, promote, perform, and organize training activities for internal departments related to quality activities, including basic statistics, DOE, GR&R, and Sample Plan designation.

· Interact with customers to ensure mutual interpretation of specified requirements, to ensure fulfillment of customer requirements and objectives are met.

· Assist the Quality Managers during customer audits and lead to the final resolution of any findings/observations resulting from the audits.

· Assist in maintaining ISO and FDA QSR quality systems compliance.

· Execute specific responsibilities as defined within the company quality operating system.

· Support and maintain all policies of the company, including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements, and Continuous Improvement initiatives.

· Identify and complete continuous improvement projects utilizing Six Sigma tools and methodologies.

· Other duties as assigned.

​

Education, Experience Requirements:

· Bachelor’s degree in engineering, Science or related field.

· 3+ years of experience in a Quality position strongly preferred.

· Experience in the Medical Device industry strongly preferred (ISO13485)

· Experience with technical writing, IQ/OQ/PQ is preferred

· Experience with equipment validation is preferred

· Experience working onsite in Manufacturing is strongly preferred

· Excellent communication skills with the ability to understand, read, write and speak English

· Must have the ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge.

· Six-sigma experience, training or certification preferred.

· Intermediate level computer skills, including Microsoft Office applications required.

· SAP experience preferred.

· Ability to work independently from verbal and/or written instructions required.

· Ability to understand and articulate how individual role and responsibilities tie into Quality department function, goals and objectives

Work Environment:

· Works in a clean manufacturing environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel.

· Ability to regularly lift up to 30 lbs with repetitive movements.

· Ability to push and pull items.

· Ability to stand, sit, walk up to 80% of a shift.

· Ability to travel between office and production departments as well as company buildings required.

· Up to 25% travel required (some international)

Company DescriptionWe are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.

Company Description

We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.