Senior Quality Engineer - Medical Devices Process Leader

Precision One Medical, Inc.; Oceanside (CA); On-site; USD 75,000 - 117,000; Full time

Job summary

Precision One Medical, Inc. is seeking a Senior Quality Engineer to lead quality initiatives across the manufacturing of medical devices.

You will improve manufacturing performance, strengthen process controls, drive validation activities, root cause investigations, and continuous improvement in a regulated setting. The role requires collaboration with cross-functional teams, CAPA leadership, supplier quality, and quality systems development while ensuring compliance with FDA QSR and ISO13485.

Qualifications

• Strong knowledge of FDA QSRs and ISO13485 requirements.
• Experience with process validation and capability studies.
• Proven ability to lead corrective actions and CAPA programs.

Responsibilities

• Adhere to Quality Management System to ensure regulatory compliance.
• Lead investigations for CAPAs, MRAs, and customer complaints with effective actions.
• Develop and standardize QA/QC processes, validation methodologies, and inspection systems.
• Provide technical leadership for process controls and product quality issues.
• Analyze quality/mfg data to identify trends and improvement opportunities using statistical methods.
• Support new product development, scale-up, and process transfers.
• Support validations and documentation change processes.
• Support supplier quality control and internal/external audits.
• Mentor junior quality engineers and report to senior management.

Skills

FDA QSR 21 CFR 820

ISO13485

SPC

DOE

Statistics

CAPA leadership

Validation

Education

Bachelor's degree in engineering (5+ years)

Master's degree in engineering (3+ years)

Job description

Precision One Medical, Inc. is seeking a Senior Quality Engineer to lead quality initiatives across the manufacturing of medical devices.

You will improve manufacturing performance, strengthen process controls, drive validation activities, root cause investigations, and continuous improvement in a regulated setting. The role requires collaboration with cross-functional teams, CAPA leadership, supplier quality, and quality systems development while ensuring compliance with FDA QSR and ISO13485.