Quality Engineer - New Product Introduction (NPI)

SaniSure LLC•Camarillo, CA

1d•$95,000 - $105,000

About The Position

The NPI Quality Engineer is responsible for ensuring quality and regulatory compliance during new product development and product transfers into manufacturing. This role partners cross-functionally with R&D, Manufacturing, Regulatory, and Supply Chain to ensure products are designed, validated, and launched in compliance with FDA, ISO 13485, and applicable regulatory requirements.

Requirements

Minimum 3 years of experience in medical device quality engineering
Experience with: FDA 21 CFR Part 820 (QSR), ISO 13485
Design Controls
Risk Management (ISO 14971)
Process validation
Strong knowledge of validation methodologies and statistical analysis
Experience participating in cross-functional development teams.
Strong technical documentation skills

Responsibilities

Serve as Quality representative on cross-functional NPI teams
Ensure compliance with 21 CFR Part 820, ISO 13485, and internal QMS requirements
Participate in design control activities including: Design planning, Design reviews, Design verification and validation, Design transfer
Lead or support risk management activities per ISO 14971
Facilitate DFMEA and PFMEA development
Ensure risk controls are implemented and verified
Support and/or lead IQ/OQ/PQ activities
Support and/or lead Process validation protocols and reports
Support and/or lead Test method validation
Support and/or lead Software validation (as applicable)
Ensure statistically sound validation approaches
Ensure manufacturing readiness for product launch
Review and approve Manufacturing instructions
Review and approve Inspection plans
Review and approve Control plans
Review and approve Device Master Records (DMR)
Support first article inspections and pilot builds
Ensure DHF documentation completeness and compliance
Support regulatory submissions (510(k), technical files, etc.) as needed
Ensure labeling and packaging compliance
Drive improvements in NPI processes
Support CAPA investigations related to NPI activities
Apply statistical tools for data-driven decision-making
Support and/or lead sterilization validation activities including: Ethylene Oxide (EO), Gamma irradiation, E-beam, Steam sterilization (as applicable)
Ensure compliance with relevant standards, such as: ISO 11135 (EO), ISO 11137 (Radiation), ISO 17665 (Moist Heat)
Participate in: Protocol development (IQ/OQ/PQ or PQ-only as applicable), Bioburden studies, Dose audits, Half-cycle or overkill validation methods, Load configuration qualification
Review and approve Sterilization validation reports
Review and approve Annual dose audits or requalification documentation
Performs additional job duties as assigned.