Sr. Product Quality Engineer

We are seeking an experienced Quality Engineer to support engineering, manufacturing, and quality operations at a leading organization in Alameda, CA.

About the role

The ideal candidate will have hands-on experience in quality engineering, manufacturing processes, SPC, process validation, CAPA, MRB, audits, and continuous improvement, preferably within a medical device or other regulated manufacturing environment.

Location: Alameda, CA 94502
Duration: 6+ month contract

Responsibilities

• Serve as the primary engineering support for In-Process Inspectors.
• Support production activities and continuous process improvements.
• Perform trend analysis, statistical analysis, SPC, and process validation activities.
• Coordinate and support In-Process MRB activities and nonconformance resolution.
• Support Quality System activities, including:
  • Quality audits
  • SOP improvements
  • Employee training
  • CAPA investigations
  • Root-cause analysis
• Support the successful transfer of new products from R&D to Production from a Quality perspective.
• Apply statistical techniques and interpret SPC data to monitor and improve manufacturing processes.
• Prepare and present Product Performance Reviews (PPR) and support Management Reviews.
• Collaborate with Engineering, Manufacturing, R&D, and Quality teams to identify and resolve production and quality issues.
• Drive continuous improvement initiatives focused on product quality, process capability, and manufacturing efficiency.

Requirements

• Quality Engineering experience
• Experience with ISO 9001, SPC, CAPA, MRB, process validation, and manufacturing

Pay

$60–$65/hr