WHK Associate Quality Engineer

7 days ago

Clearwater, United States T S E INDUSTRIES INC. Full time

Description:

SALARY

$50,000-$60,000


SUMMARY

The 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 Assurance

  • Assist 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 plans
  • Assist 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 directed
  • Participate in the initiation and resolution of CAPAs
  • Update, 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 Control

  • Perform Final Product Release, Incoming Inspection and Release, Production Inspection, NonConformances, DMRs, Calibration (via GagePack) and Label Approvals
  • Perform 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 TRAINING

To perform this job successfully, an individual must complete and maintain the following Safety Training requirements.

General Safety Orientation


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 EXPERIENCE

  • Minimum 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 required
  • Energetic, with strong interpersonal, organizational and communication skills are required
  • Excellent verbal and written communication skills are required.
  • Demonstrated ability to accomplish work goals is required
  • Quality 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 SKILLS

Must 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 SKILLS

An understanding of all basic mathematical skills.


REASONING ABILITY

Should 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 moderate



Compensation details: 50000-60000 Yearly Salary



PI8122a8b3c0f5-31181-35372191

  • WHK Associate Quality Engineer

    1 month ago

    Clearwater, United States T S E INDUSTRIES INC. Full time

    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...

  • WHK Associate Quality Engineer

    2 weeks ago

    Clearwater, United States T S E INDUSTRIES INC. Full time

    Job DescriptionJob DescriptionDescription: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 Assurance Engineer

    1 week ago

    Clearwater, United States T S E INDUSTRIES INC. Full time

    Job Title: WHK Associate Quality EngineerJob Summary:The Associate Quality Engineer will work under the direction of the Senior Quality Engineer and/or Quality Manager to assist with all aspects of WHK Quality. This includes customer complaints, training, Quality Metrics, Audits, CAPAs, Quality Documentation, and Quality Control.Key Responsibilities:Assist...

  • Quality Assurance Engineer

    4 weeks ago

    Clearwater, Florida, United States T S E INDUSTRIES INC. Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Engineer to join our team at TSE Industries Inc. as a WHK Associate Quality Engineer. The successful candidate will be responsible for ensuring the quality of our products and processes, and will work closely with our engineering and production teams to identify and implement...

  • Quality Assurance Engineer

    4 weeks ago

    Clearwater, Florida, United States T S E INDUSTRIES INC. Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Engineer to join our team at TSE Industries Inc. as a WHK Associate Quality Engineer. The successful candidate will be responsible for ensuring the quality of our products and processes, and will work closely with our engineering and production teams to identify and implement...

  • Quality Assurance Specialist

    7 days ago

    Clearwater, United States T S E INDUSTRIES INC. Full time

    Job Title: WHK Associate Quality EngineerJob Summary:The Associate Quality Engineer will work under the direction of the Senior Quality Engineer and/or Quality Manager to assist with all aspects of WHK Quality. This includes customer complaints, training, Quality Metrics, Audits, CAPAs, Quality Documentation, and Quality Control.Key Responsibilities:Assist...

  • Quality Assurance Specialist

    1 week ago

    Clearwater, United States T S E INDUSTRIES INC. Full time

    Job Title: WHK Associate Quality EngineerJob Summary:The Associate Quality Engineer will work under the direction of the Senior Quality Engineer and/or Quality Manager to assist with all aspects of WHK Quality. This includes customer complaints, training, Quality Metrics, Audits, CAPAs, Quality Documentation, and Quality Control.Key Responsibilities:Assist...

  • Quality Assurance Engineer

    4 weeks ago

    Clearwater, United States T S E INDUSTRIES INC. Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Engineer to join our team at TSE Industries Inc. as an Associate Quality Engineer. This role will be responsible for assisting the Senior Quality Engineer and/or Quality Manager in all aspects of WHK Quality, including customer complaints, training, Quality Metrics, Audits,...

  • WHK Clean Room Operator I

    4 weeks ago

    Clearwater, United States TSE Industries Full time

    Description: HOURS OF OPERATION: M-TH 5a.m. - 3:30p.m. SALARY $15/hour CLEAN ROOM OPERATOR SUMMARY The cleanroom operator is responsible for assembling, testing, inspecting, and packaging medical devices per work instructions using a variety of assembly equipment, fixtures and test equipment. Technician works on assignments that are semi-routine in nature,...

  • WHK Clean Room Operator I

    2 weeks ago

    Clearwater, United States T S E INDUSTRIES INC. Full time

    Job DescriptionJob DescriptionDescription:HOURS OF OPERATION:M-TH 5a.m. - 3:30p.m. SALARY$15/hourCLEAN ROOM OPERATOR SUMMARYThe cleanroom operator is responsible for assembling, testing, inspecting, and packaging medical devices per work instructions using a variety of assembly equipment, fixtures and test equipment. Technician works on assignments that are...

  • WHK Clean Room Operator I

    1 week ago

    Clearwater, United States TSE Industries Full time

    Job Type Full-time Description HOURS OF OPERATION: M-TH 5a.m. - 3:30p.m. SALARY $15/hour CLEAN ROOM OPERATOR SUMMARY The cleanroom operator is responsible for assembling, testing, inspecting, and packaging medical devices per work instructions using a variety of assembly equipment, fixtures and test equipment. Technician works on assignments that are...

  • WHK Clean Room Operator I

    1 week ago

    Clearwater, United States Disability Solutions Full time

    Description:HOURS OF OPERATION:M-TH 5a.m. - 3:30p.m. SALARY$15/hourCLEAN ROOM OPERATOR SUMMARYThe cleanroom operator is responsible for assembling, testing, inspecting, and packaging medical devices per work instructions using a variety of assembly equipment, fixtures and test equipment. Technician works on assignments that are semi-routine in nature, where...

  • Quality Assurance Engineer

    4 weeks ago

    Clearwater, Florida, United States Southwire Company LLC Full time

    Job OverviewSouthwire Company, LLC is seeking a highly skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality of our products and services.Key ResponsibilitiesDevelop and implement quality control plans, testing protocols, and inspection procedures to ensure products meet...

  • Quality Assurance Engineer

    1 month ago

    Clearwater, Florida, United States AMERICAN TOOL & MOLD Full time

    Position OverviewEmpowering Excellence in ManufacturingAt American Tool & Mold, we are dedicated to the art of precision and the innovation that drives our industry forward. As a pivotal member of our team, the Quality Engineer will be instrumental in upholding our AS9100D and ISO13485 Certifications.Key Responsibilities:Quality Assurance: Evaluate design...

  • Quality Assurance Engineer

    1 month ago

    Clearwater, Florida, United States T S E INDUSTRIES INC. Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Engineer to join our team at TSE Industries Inc. The successful candidate will be responsible for ensuring the quality of our products and processes, and will work closely with cross-functional teams to identify and implement improvements.Key ResponsibilitiesAssist in the...

  • Quality Assurance Engineer

    7 days ago

    Clearwater, United States Butler Aerospace and Defense Full time

    Quality Assurance Engineer Location: Clearwater, FL Job ID: #69965 Pay Range: $37-62/hr 12 monthsMUST HAVE AN ACTIVE SECRET CLEARANCEJob Description Applies quality principles in the areas of: design, incoming material, production control, product evaluation, program performance, reliability, inventory control, and/or research and development as they apply...

  • Quality Engineer Lead

    1 month ago

    Clearwater, Florida, United States AMERICAN TOOL & MOLD Full time

    Job Summary:The Senior Quality Engineer will provide experienced quality assurance support to the product development team, document and submit 510K to FDA, Lead CAR resolving of defects and ensuring the product meets customer specifications and regulatory requirements.Key Responsibilities:Initiates FDA 510K documentation and successfully submitted to the...

  • Supplier Quality Engineer

    6 days ago

    Clearwater, United States Nesco Resource Full time

    Job Description:Applies quality principles in the areas of: design, incoming material, production control, product evaluation, program performance, reliability, inventory control, and/or research and development as they apply to product or process quality for make and/or buy products. Performs technical evaluations including product requirements,...

  • Structural Engineer

    1 month ago

    Clearwater, United States Pennoni Full time

    Pennoni is a multidisciplinary consulting engineering firm founded more than five decades ago. We approach engineering challenges from a wider spectrum of angles than most, from land development to energy management. Our goal is to help communities and private sector clients alike navigate the ever-changing technological advancements available and learn how...

  • Quality Assurance Manager

    6 days ago

    Clearwater, United States Kelly Science, Engineering, Technology & Telecom Full time

    Quality Assurance ManagerKelly Science, Engineering, Technology & Telecom is seeking a highly skilled Quality Assurance Manager to lead our quality assurance efforts in the aerospace industry.Job SummaryThe Quality Assurance Manager will be responsible for ensuring that all aspects of quality assurance are in full compliance with FAA, AS9100, and key...