WHK Associate Quality Engineer
Company: T S E INDUSTRIES INC.
Location: Clearwater
Posted on: October 2, 2024
|
|
Job Description:
Description:SALARY$50,000-$60,000SUMMARYThe Associate Quality
Engineer will work under the direction of the Senior Quality
Engineer and/or Quality Manager. The Associate Quality Engineer
will assist with all aspects of WHK Quality, including but not
limited to customer complaints, training, Quality Metrics, Audits,
CAPAs, Quality Documentation, and Quality Control.ESSENTIAL DUTIES
AND RESPONSIBILITIES include the following. Other duties may be
assigned.Quality AssuranceAssist the team in problem solving to
identify root causes and corrective actions/preventive
actions.Assist in creating and revising assembly procedures.Provide
support to Engineering Projects via Engineering Change Orders
(ECO). This includes but is not limited to the creation, review and
approval of procedures, specifications, inspection plans and
quality records.Assist the Senior Quality Engineer and/or Quality
Manager maintaining Quality Metrics and KPIs. Perform trend
analysis and identify action plansAssist the Senior Quality
Engineer and/or Quality Manager to prepare for customer audits and
third party audits.Participate in customer/external audits and
assist the Senior Quality Engineer and/or Quality Manager with any
preparation or reporting as directedParticipate in the initiation
and resolution of CAPAsUpdate, evaluate returned product under RMA
process; interface with customer service and/or customer as
necessary.Report improvements to management and appropriate
cross-functional teams.Lead and participate in other projects as
needed.Quality ControlPerform Final Product Release, Incoming
Inspection and Release, Production Inspection, NonConformances,
DMRs, Calibration (via GagePack) and Label ApprovalsPerform and
oversee the review, storage and disposition of Quality records in
accordance with cGMP and ISO13485:2016.Communicate with vendors
when necessary to request vendor certifications and other documents
e.g. First Articles as required.Oversee preventive maintenance for
tools and fixtures to ensure that PM tasks are performed accurately
and in a timely manner.Perform and oversee the review, storage and
disposition of Quality records in accordance with cGMP and
ISO13485:2016.Work with Quality, Engineering, and Production QC
inspector(s) and/or production to resolve non-conformances in a
timely manner so as to meet specified shipment dates.Assist in
orientation of new technicians and inspection processes, as
necessary.Prepare Certifications for shipments.Assist the Senior
Quality Engineer and/or Quality Manager in processing rejects and
returns by utilizing Epicor ERP.Assist in identifying and
implementing areas for quality control improvement.Communicate
quality or compliance concerns with urgency.Teamwork is essential
for TSE's continued success, so Teamwork is an essential function
of every employee's job. Teamwork drives positive results every
day. Teamwork promotes positive customer relations and results in
exceeding the expectations of our customers. Teamwork benefits
every employee since it grows our business and increases our sales.
With Teamwork, we all succeed. Without it, we all suffer. Teamwork
with co-workers in the same department is just the beginning.
Teamwork with every other employee, department and division is the
Teamwork that is required to succeed. WE ARE
TSE.Requirements:SAFETY TRAININGTo perform this job successfully,
an individual must complete and maintain the following Safety
Training requirements.General Safety OrientationQUALIFICATIONSTo
perform this job successfully, an individual must be able to
perform each essential duty satisfactorily. The requirements listed
below are representative of the knowledge, skill, and/or ability
required. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential
functions.EDUCATION AND/OR EXPERIENCEMinimum of a high school
degree or GED is required. A BA/BS in a technical or engineering
field is preferred.A minimum of 2 years experience working in a
professional office and manufacturing environment is
required.Ability to define problems, collect data, establish facts
and draw valid conclusions is requiredEnergetic, with strong
interpersonal, organizational and communication skills are
requiredExcellent verbal and written communication skills are
required.Demonstrated ability to accomplish work goals is
requiredQuality Engineering experience in the Medical Device or
similar field is preferred.Experience with statistical analysis,
root cause problem solving, and validations is preferred.Cleanroom
experience is a plus.GMP experience in an FDA/Health Canada/ISO
regulated industry or similar is a plus.LANGUAGE SKILLSMust possess
the ability to express thoughts clearly, both verbally and in
written context. Must have strong knowledge in working with the MS
Office Suite.MATHEMATICAL SKILLSAn understanding of all basic
mathematical skills.REASONING ABILITYShould be familiar with the
different processes required to process materials through a
manufacturing environment. This knowledge would help the individual
to be able to install necessary inspection points throughout the
manufacturing operations.PHYSICAL DEMANDS The physical demands
described here are representative of those that must be met by an
employee to successfully perform the essential functions of this
job. Reasonable accommodations may be made to enable individuals
with disabilities to perform the essential functions.While
performing the duties of this job, the employee is regularly
required to talk or hear. The employee is frequently required to
stand, walk and use hands to finger, handle, or feel. The employee
is occasionally required to sit. The employee must frequently lift
and/or move up to 50 - pounds. Specific vision abilities required
by this job include close vision, peripheral vision, depth
perception and ability to adjust focus. Must have the ability to
travel for business purposes.WORK ENVIRONMENT The work environment
characteristics described here are representative of those an
employee encounters while performing the essential functions of
this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential
functions.While performing the duties of this job, the employee is
occasionally exposed to moving mechanical parts and environmental
restrictions. The noise level in the work environment is usually
moderateCompensation details: 50000-60000 Yearly
SalaryPIbee5b7d1f3d5-25660-35372191
Keywords: T S E INDUSTRIES INC., Ocala , WHK Associate Quality Engineer, Engineering , Clearwater, Florida
Click
here to apply!
|