Senior Quality Engineer - Process Excellence & CAPA Leader

Precision One Medical, Inc.; California; On-site; USD 95,000 - 150,000; Full time

Job summary

Precision One Medical, Inc. is seeking a Senior Quality Engineer to lead quality initiatives across manufacturing, focusing on process controls, validation, and continuous improvement.

The role collaborates with cross-functional teams to strengthen QA/QC, drive CAPA effectiveness, and support quality system initiatives in a fast-paced medical device environment. The candidate will work onsite in Oceanside, CA, with a strong emphasis on regulatory compliance, data-driven decision making, and

Qualifications

• Bachelor's or Master's degree in engineering with relevant experience.
• Strong knowledge of regulatory requirements (FDA QSR, ISO13485).
• Proven experience in quality systems and CAPA.

Responsibilities

• Adhere to Quality Management System and regulatory requirements.
• Lead CAPA investigations and ensure effective actions.
• Develop standardized QA/QC processes and validation methods.
• Provide technical leadership on manufacturing controls and inspection methods.
• Analyze data to identify trends and opportunities for improvement.
• Support validations, documentation changes, supplier quality, and audits.
• Mentor junior quality engineers and report to senior management.

Skills

FDA QSR 21 CFR Part 820 & ISO 13485

Statistical methods & DOE

CAPA investigations

Root cause analysis

Leadership / mentoring

Education

Bachelor's degree in engineering (5+ years)

Master's degree in engineering (3+ years)

Tools

SPC software

DOE software

Job description

Precision One Medical, Inc. is seeking a Senior Quality Engineer to lead quality initiatives across manufacturing, focusing on process controls, validation, and continuous improvement.

The role collaborates with cross-functional teams to strengthen QA/QC, drive CAPA effectiveness, and support quality system initiatives in a fast-paced medical device environment. The candidate will work onsite in Oceanside, CA, with a strong emphasis on regulatory compliance, data-driven decision making, and