Quality Engineer
Company: NEMERA
Location: Buffalo Grove
Posted on: September 8, 2023
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Job Description:
Job DescriptionThe 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.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.Preferred/Required
Education/Skills: 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 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 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 objectivesWork 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).
Keywords: NEMERA, Buffalo Grove , Quality Engineer, Engineering , Buffalo Grove, Illinois
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