Senior Quality Engineer – SPC, CAPA & Process Validation

Experis; Alameda (CA); On-site; USD 83,000 - 90,000; Full time

Job summary

Experis in Alameda, CA is seeking an experienced Quality Engineer to support engineering, manufacturing, and quality operations. The role requires hands-on experience in quality engineering, manufacturing processes, SPC, process validation, CAPA, MRB, audits, and continuous improvement, ideally within a medical device or regulated environment. Location: Alameda, CA 94502.

Pay rate: $60-65/hr. Duration: 6+ month contract.

Qualifications

• Hands‑on experience in quality engineering, manufacturing processes, SPC, process validation, CAPA, MRB, audits, and continuous improvement.
• Experience in regulated manufacturing environments, preferably medical devices.

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, and root‑cause analysis.
• Support the transfer of new products from R&D to Production from a Quality perspective.
• Apply 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 resolve issues.
• Drive continuous improvement initiatives focused on product quality and manufacturing efficiency.

Skills

Quality Engineer

SPC

Process Validation

CAPA

MRB

Audits

Continuous Improvement

Job description

Experis in Alameda, CA is seeking an experienced Quality Engineer to support engineering, manufacturing, and quality operations. The role requires hands-on experience in quality engineering, manufacturing processes, SPC, process validation, CAPA, MRB, audits, and continuous improvement, ideally within a medical device or regulated environment. Location: Alameda, CA 94502.

Pay rate: $60-65/hr. Duration: 6+ month contract.