Quality Engineer I - Process & CAPA Specialist

Paylocity; San Diego (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

Providien Thermoforming is seeking a Quality Engineer I to lead and support quality activities on the shop floor. You will oversee inspections, audits, CAPAs, and process improvements for thermoformed components across medical device and aerospace markets.

Ideal candidates have a technical engineering background, ISO 13485 knowledge, and hands-on experience with quality tools, PPAPs, and FMEA. This role emphasizes data-driven problem solving and cross-functional teamwork.

Qualifications

• Bachelor’s degree in engineering or sciences.
• 5+ years' technical engineering experience preferred.
• 3 years manufacturing experience preferred.
• Knowledge of ISO 13485:2016 and related standards preferred.
• Experience in medical device, aerospace, or plastics/thermoforming industries preferred.

Responsibilities

• Provide daily quality support to manufacturing and engineering, including inspection, assembly, packaging and shipping.
• Investigate nonconforming products, scrap, rework and customer complaints; identify root causes and corrective actions.
• Lead or support CAPAs using 5 Whys, fishbone diagrams, and data analysis.
• Develop and maintain inspection plans, work instructions, acceptance criteria and manufacturing quality records.
• Review production documentation for GDP compliance and accuracy.
• Partner with manufacturing and engineering on process changes, validation, risk assessment and FAI.
• Use trend data and quality metrics to identify recurring issues and drive improvements.
• Support supplier quality activities and corrective actions.
• Participate in internal, customer and ISO 13485 audits; help prepare responses and close findings.
• Train and coach employees on quality requirements and procedures.
• Develop and deliver quality training materials to raise awareness.
• Review customer specifications; participate in FMEAs, DOE, PPAPs and CAPAs.
• Continuously improve quality systems and processes.

Skills

Attention to detail

Team collaboration

English communication

Education

Bachelor's degree in engineering or sciences

5+ years in technical engineering

3 years manufacturing experience

CQE or CQPA certification

Six Sigma Green Belt

Tools

MS Office Suite

SharePoint

ERP systems

GD&T

Blueprint reading

ASME Y14.5M

Job description

Providien Thermoforming is seeking a Quality Engineer I to lead and support quality activities on the shop floor. You will oversee inspections, audits, CAPAs, and process improvements for thermoformed components across medical device and aerospace markets.

Ideal candidates have a technical engineering background, ISO 13485 knowledge, and hands-on experience with quality tools, PPAPs, and FMEA. This role emphasizes data-driven problem solving and cross-functional teamwork.