Careers

Quality Engineer

    • Job Tracking ID: 512885-800461
    • Job Location: Des Moines, IA
    • Job Level: Mid Career (2+ years)
    • Level of Education: BA/BS
    • Job Type: Full-Time/Regular
    • Date Updated: December 08, 2021
    • Years of Experience: 2 - 5 Years
    • Starting Date: ASAP
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Job Description:

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

  1. Designs, installs, and evaluates quality process sampling systems, procedures, and statistical techniques.
  2. 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.
  3. Work with other departments to determine the root cause and solve problems involved with product quality.
  4. Analyze production and service limitations and standards.
  5. Formulates or helps formulate quality policies, procedures, and work instructions.
  6. Conducts training on quality concepts or tools.
  7. Works with customers for First Article Approval and to resolve quality issues as required.
  8. Audits Business Management Systems, i.e. ISO 13485 and FDA, Title 21 Part 820, QSR, etc. at Katecho and its supply base.
  9. Participates in external quality audits performed by 3rd party auditors.
  10. Issues and reviews supplier correction actions, to prevent any problem trends from occurring.
  11. Reviews ECO’s (Engineering Change Orders), requesting or authorizing changes as needed.
  12. Coordinates documentation of process using ISO format.
  13. Take necessary action required to remedy product quality problems; such as quarantining product or shutting down production, etc.

Experience and Skills:

  1. Bachelor’s degree in Engineering, Manufacturing or Business preferred.

  2. 3-5 years experience working within quality engineering systems.

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

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

  5. Experience in SPC and Statistical Analysis.

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

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

  8. Strong commitment to quality and customer service.

  9. Demonstrated problem solving skills required.

Benefits

Full Benefits package including Medical, Dental, Vision, Flex, Life insurance, Voluntary life insurance, Short term disability and Long term disability insurance, and 401k. 

3 weeks of PTO upon hire