Quality Assurance Specialist

1 week ago

Clearwater, United States T S E INDUSTRIES INC. Full time
Job Title: WHK Associate Quality Engineer

Job 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 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).
  • Assist the Senior Quality Engineer and/or Quality Manager in maintaining Quality Metrics and KPIs.
  • Assist in preparing for customer audits and third-party audits.
  • Participate in customer/external audits and assist 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.

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.
  • Oversee preventive maintenance for tools and fixtures to ensure that PM tasks are performed accurately and in a timely manner.
  • Work with Quality, Engineering, and Production QC inspector(s) and/or production to resolve non-conformances in a timely manner.
  • 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.

Requirements:

  • 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.

Language Skills:

Must possess the ability to express thoughts clearly, both verbally and in written context.

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.

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.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

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