quality engineer Long Beach, CA
Job description
SUMMARY
The Quality Engineer is responsible for implementing and maintaining the ISO 13485:2016 quality system requirements at SPSA.
RESPONSIBILITIES & DUTIES
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. o 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. o 100% supplier lot acceptance
● Conducts supplier audits, including qualification of new suppliers.
● New customer Quality Engineering product qualification support. o IQ (installation qualification) o OQ (operation qualification) o 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 AND SKILL REQUIREMENTS:
● 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 Opportunity Employer
Job Type: Full-time
Pay: $80,000.00 - $110,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Evening shift
- Monday to Friday
- Night shift
- Weekends as needed
Work Location: In person
