Senior Quality Engineer: Manufacturing & CAPA Leader

Precision One Medical; Oceanside (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

Precision One Medical is seeking a Senior Quality Engineer to lead quality initiatives across manufacturing. You will support validations, drive process controls, and mentor junior engineers in a collaborative, regulated environment.

The role emphasizes data-driven improvements, regulatory compliance with FDA QSR and ISO13485, and cross-functional teamwork to ensure product quality and successful audits.

Qualifications

• Bachelor's degree in engineering with 5+ years of experience.
• Master's degree in engineering with 3+ years of experience.
• ASQ certification preferred (e.g., Quality Engineer, Auditor).

Responsibilities

• Adhere to Quality Management System to ensure regulatory compliance.
• Lead investigations for CAPAs, NMRs, and customer complaints with effective, measurable actions.
• Develop and standardize QA/QC processes, validation methodologies, inspection systems, and manufacturing controls.
• Provide technical leadership for manufacturing process controls and product quality issues.
• Analyze quality and manufacturing data to identify trends and improvement opportunities using statistics and risk-based logic.
• Support validations, documentation change processes, supplier quality control, and audit programs.
• Mentor junior quality engineers and communicate status to senior management.
• Collaborate with other departments to drive continuous improvement.

Skills

FDA QSR 21 CFR 820 knowledge

ISO13485 knowledge

SPC

DOE

statistical methods

Education

Bachelor's in engineering (5+ yrs)

Master's in engineering (3+ yrs)

Tools

ASQ Certification

Job description

Precision One Medical is seeking a Senior Quality Engineer to lead quality initiatives across manufacturing. You will support validations, drive process controls, and mentor junior engineers in a collaborative, regulated environment.

The role emphasizes data-driven improvements, regulatory compliance with FDA QSR and ISO13485, and cross-functional teamwork to ensure product quality and successful audits.