NEMERA · 1 day ago
Quality Engineer - Validation
Buffalo Grove, IL
Full-time
Onsite
Mid Level
$85K/yr - $105K/yr
3+ years expNemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology and generic industries. The Quality Validation Engineer is responsible for planning, coordinating, and managing projects to ensure product quality and compliance, while also leading investigations and managing supplier performance.
BiotechnologyHealth CareManufacturingMedical Device
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 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, selects 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 relationship to assigned tasks to determine 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 ensures 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 assure mutual interpretation of specified requirements to ensure fulfilment of customer requirements and objectives are met
Assist the Quality Managers during customer audits and lead to final resolution 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
Qualification
Required
Bachelor's degree in Engineering, Science or related field required
Excellent communication skills with the ability to understand, read, write and speak English required
Must have the ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge
Intermediate level computer skills, including Microsoft Office applications required
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
Preferred
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
Six-sigma experience, training or certification preferred
SAP experience preferred
Company
NEMERA
Nemera is one of the world leaders in the design, development and manufacturing of high quality innovative drug delivery solutions.
1001-5000 employees
H1B Sponsorship
NEMERA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (1)
2022 (1)
2021 (3)
Funding
Current Stage
Late StageTotal Funding
unknown2018-10-17Acquired
Leadership Team
Marc Haemel
CEO & Founder
Claude Menenteau
VP of Operations
Recent News
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