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Katecho Quality Engineer, M-F in Des Moines, Iowa

Quality Engineer, M-F

+ + Job Tracking ID: 512885-770461

  • Job Location: Des Moines, IA

  • Job Level: Mid Career (2+ years)

  • Level of Education: BA/BS

    • Job Type: Full-Time/Regular
  • Date Updated: May 03, 2021

  • Years of Experience: College

  • Starting Date: May 3, 2021

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    Job Description:

    Job Title

    Product Quality Engineer I

    Position/Level

Engineer I

FLSA Status

Salary Exempt

Department

Product Engineering

Reports to

Product Engineering Manager

Direct Reports

None

SUMMARY

Responsible for designing, installing, and performing risk assessments of quality process systems and statistical techniques internal to Katecho as well as at suppliers. Formulates quality policies, procedures and work instructions. Works with customers for First Article Approval. Proactively work and communicate with all departments in the area of quality with the goal of Continuous Improvement. This position supports the Engineering job functions of Quality Assurance to meet organizational objectives.

PRIMARY DUTIES AND RESPONSIBILITIES

  • Develops and executes installation, operation and performance qualification protocols for equipment and systems.

  • Designs, installs, and evaluates quality process sampling systems, procedures, and statistical techniques.

  • Proactively work on continuous improvement of the quality system through monitoring of production operations, personnel management, and adherence to and administration of ISO 13485 and FDA, Title 21 Part 820, QSR.

  • Work with other departments to determine the root cause and solve problems involved with product quality.

  • Analyze production and service limitations and standards.

  • Formulates or helps formulate quality policies, procedures, and work instructions.

  • Conducts training on quality concepts or tools.

  • Works with customers for First Article Approval and to resolve quality issues as required.

  • Audits Business Management Systems, i.e. ISO 13485 and FDA, Title 21 Part 820, QSR, etc. at Katecho and its supply base.

  • Participates in external quality audits performed by 3rd party auditors.

  • Issues and reviews supplier correction actions, to prevent any problem trends from occurring.

    SECONDARY DUTIES AND RESPONSIBILITIES

  • Reviews ECO’s (Engineering Change Orders), requesting or authorizing changes as needed.

  • Acts as a leader within the organization demonstrating Katecho’s core values and effectively implementing the Company’s strategy.

  • Coordinates documentation of process using ISO format.

    AUTHORITY

  • Take necessary action required to remedy product quality problems; such as quarantining product or shutting down production, etc.

  • Determine and request necessary resources (personnel, equipment, supplies, etc.) to effectively run the Quality Department.

  • Work together with members of the management team to manage the overall direction of Katecho.

  • Must complete a Non-Compete Agreement and Patent Agreement.

    Experience and Skills:

    QUALIFICATIONS

    1. Education and/or Experience
  • Bachelor’s degree in Engineering, Manufacturing or Business preferred.

  • 3-5 years’ experience working within quality engineering systems.

  • Experience working with business management systems particularly ISO 13485 preferred, and FDA Title 21 Part 820, QSR.

  • ASQ Quality Engineer Certified within one (1) year.

  • Experience in SPC and Statistical Analysis.

  • Computer skills in MS-Office and Statistical Analysis Software.

  • Self-Motivated analytical data driven decision maker with strong leadership skills.

  • Strong commitment to quality and customer service.

  • Demonstrated problem solving skills required.

    1. Leadership Ability
  • a. Able to lead and influence other employees in the areas of work performance, work quality, dependability, and company loyalty.

    1. Reasoning Ability
  • a. Able to solve practical problems with a variety of variables in situations where only limited standardization exists.

  • Able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

  1. Language/Communication Skills
  • Able to read, analyze, and interpret general business periodicals, reports, technical procedures, and/or government regulations.

  • Able to write reports, business correspondence, as well as internal procedures and instructions.

  • Strong written and verbal communication skills.

  • Able to effectively present information and respond to questions from customers, managers, and employees.

    Benefits

    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 frequently required to stand, walk, sit and operate a computer. Specific vision abilities required by this job include close vision, distance vision, and color determination.

WORK ENVIRONMENT

Office environment with business casual dress. May require business attire. Requires working in a test lab facility with electrical equipment.

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