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