Quality Engineer

Job Information

• Work Experience: 3-10 years
• Salary: $80,000 to $110,000

• City: Long Beach

• State/Province: CA

• Country: United States

• Zip/Postal Code: 90805

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.

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