Description

You will own quality assurance and validation activities for medical devices.

Responsibilities

• Execute and document process and equipment validations (IQ/OQ/PQ).
• Develop and author GMP compliant validation protocols and reports.
• Support V&V, TMV, and requirements traceability per Design Controls (21 CFR 820.30).
• Perform statistical analysis using MiniTab (Gage R&R, SPC, DOE).
• Develop and maintain PFMEA, Control Plans, and risk documentation (ISO 14971).
• Support design transfer, CAPA, change control, and QMS harmonization initiatives.

Required Skills

• 3+ years of QE/Validation experience in regulated medical device environments.
• Strong ISO 13485 QMS experience.
• Working experience with SAP and Siemens Teamcenter.
• Knowledge of FDA QSR, cGMP, and Design Controls.
• Strong documentation, analytical, and communication skills.
• Experience with Fda and Sap systems.

Preferred Skills

• Spanish speaking ability.
• Ability to travel to Tijuana as required.

Key Skills

Education

Any Gradute