WHK Quality Director
Company: T S E INDUSTRIES INC.
Location: Clearwater
Posted on: August 4, 2022
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Job Description:
Description:
SUMMARYLeads WHK Quality and Regulatory Departments to assure
compliance with WHK's Quality Management System and all applicable
regulatory requirements to ensure a best-in-class quality
culture.ESSENTIAL DUTIES AND RESPONSIBILITIES include the
following. Other duties may be assigned.Develop, implement,
maintain and continually improve the WHK Quality Management
System.Lead MRB meeting, ensure implementation of corrective
actions and update NMR database.Management of Quality Engineers and
Quality Inspectors to ensure QMS procedures and policies are
followed.Develop strategic quality improvement initiatives that
establish a culture of quality.Act as the primary interface with
the customer and all regulatory agencies regarding all quality
related questions, concerns or inquiries.Conduct ISO Awareness
Training, cGMP Training and overall Compliance training with all
WHK employees.Manage and make process improvements to the ECO
process for new products launches and product/process changes.Work
closely with Purchasing to supervise WHK Supplier Management
Program.Develop, implement, and coordinate control plans and
documentation for new and existing manufactured parts.Development
and maintain visual aids for defect recognition. Train appropriate
personnel on the use of the visual aids for defect recognition
system.Develop and maintain operation specific work instructions
and inspection standards. Train appropriate personnel on the use of
these work instructions and inspection standards.Conduct capability
studies, analyze results and report results as needed to
management.Create and maintain control plans and control charts as
necessary.Identify critical characteristics to be inspected for
each part run in WHK manufacturingConduct root cause analysis for
discrepancies and issue corrective action when deemed
necessary.Update, evaluate returned product under RMA process;
interface with customer service and/or customer as necessary.Lead
the initiative to drive down defect rates by determining which
parts need attention. As a team leader, working directly with
involved departments, the Quality Director is to systematically
identify and correct the root cause of all product
defects.SUPERVISORY RESPONSIBILITIESSupervise WHK Quality Manager,
Quality Engineers and QA Inspectors.Carry out supervisory
responsibilities in accordance with the organization's policies and
applicable laws.Responsibilities include training employees;
planning, assigning, and directing work; appraising performance;
rewarding and disciplining employees; addressing complaints and
resolving problems.Teamwork is essential for WHK'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 WHK..
Requirements:
SAFETY TRAINING To perform this job successfully, an individual
must complete and maintain the following Safety Training
requirements.General Safety Orientation**CD-ROM course tailored to
specific individual requirements within their job ''Training
Suite".QUALIFICATIONS To 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 EXPERIENCEA
minimum of ten years of experience in a leadership position within
both Quality Assurance and Regulatory responsibilities. Must have a
strong knowledge of ISO 13485 and other quality systems. Experience
leading FDA/customer inspections is required. Prior experience in
the Medical Device or Single Use Medical market is required. Prior
experience with sterile products 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. A complete understanding of trigonometry and
angular relationships is necessary in order to understand and
interpret blueprints.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.CERTIFICATES, LICENSES, REGISTRATIONSAn
active membership in the American Society for Quality (ASQ) and an
ASQ CQE are a plus.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 frequently is 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 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.PI184708587
Keywords: T S E INDUSTRIES INC., Clearwater , WHK Quality Director, Executive , Clearwater, Florida
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