Location: Buffalo Grove
Posted on: September 9, 2023
The Quality Validation Engineer is responsible for planning,
coordinating and managing through completion, assigned projects to
ensure the development and production of products meets 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.
- 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
- 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
- Assist in maintaining ISO and FDA QSR quality systems
- 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
- Identify and complete continuous improvement projects utilizing
Six Sigma tools and methodologies.
- Other duties as assigned. Preferred/Required Education/Skills:
- Bachelor's degree in Engineering, Science or related
- 3+ years' of experience in a Quality position strongly
- Experience in the Medical Device industry strongly preferred
- Experience with technical writing, IQ/OQ/PQ is preferred
- Experience with equipment validation is preferred
- Experience working onsite in Manufacturing is strongly
- 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.
- Six-sigma experience, training or certification preferred.
- Intermediate level computer skills, including Microsoft Office
- SAP experience preferred.
- Ability to work independently from verbal and/or written
- 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
- Ability to regularly lift up to 30 lbs with repetitive
- 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).
Keywords: NEMERA, Buffalo Grove , Quality Engineer, Engineering , Buffalo Grove, Illinois
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