Quality Engineer

Modesto, CA, United States

Job Information

  • Work Experience: 3-10 years
  • Salary: $80,000 to $110,000
  • City: Modesto
  • State/Province: CA
  • Country: United States
  • Zip/Postal Code: 95350

Job Description

SUMMARY

The Quality Engineer is responsible for implementing and maintaining the ISO 13485:2016 quality system requirements at SPSA.

PRIMARY RESPONSIBILITIES:

  • Must be a team player as measured by his/her peers.
  • Foster and develop quality system to ensure no internal defects ship to customers.
    • 100% customer lot acceptance.
  • Analyze failure, corrective, and preventive action to respond to customer complaints.
  • Incoming, in-process, and final inspection support.
  • Continuously improving QA inspection work instructions, process and procedures.
  • Provide guidance to inspectors in scheduling the priorities of the department.
  • Quality system improvement planning and implementation.
  • Supplier development, validation, and supplier quality.
  • Ensure timely resolution of supplier failure, corrective actions, and preventive actions.
  • Develop quality system to ensure all sub-contract manufactures meet SPSA requirements.
    • 100% supplier lot acceptance
  • Conducts supplier audits, including qualification of new suppliers.
  • New customer Quality Engineering product qualification support.
    • IQ (installation qualification)
    • OQ (operation qualification)
    • PQ (product qualification)
  • Internal process corrective action support.
  • Supporting root cause analysis and implementation of corrective action for all process related concerns.
  • Responsible for assisting with continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
  • Interface with Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data.
  • Conducts internal and supplier audits, including closing out audit findings, creating audit finding reports and determine proper corrective and preventive actions.
  • Preparation of QA reports.
  • Monitor outside service contractor’s capabilities.

ADDITIONAL RESPONSIBILITIES:

  • Represent the company’s quality system externally to media, government agencies, funding agencies, the general public.

  • Additional duties as assigned by management

SUPERVISORY RESPONSIBILITIES:

None

WORKING CONDITIONS:

Work is performed in a fast-paced indoor production area with little exposure to dust and high temperatures; moderate exposure to excessive noise; climate-controlled environment; and controlled access. Possible exposure to infectious materials and strong odorous chemicals or elements.

TRAVEL REQUIRED:

None

Qualification Requirements

EXPERIENCE:

3 to 10 years of progressive ISO 13485 quality assurance experience.

EDUCATION/CERTIFICATION:

Bachelor’s degree (B.A./B.S.) of Science in Engineering, Chemistry or related field or equivalent.

KNOWLEDGE, SKILLS, ABILITIES:

  • Excellent verbal and written communication skills.

  • Excellent organizational skills and attention to detail.

  • Extensive knowledge of or the ability to quickly learn the organizations production processes.

  • Strong analytical and problem-solving skills.

SPSA IS AN EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER
SPSA offers competitive compensation and comprehensive benefits.

Resumes should be submitted to careers@spsausa.com

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