Quality Engineer - New Product Introduction (NPI)

Quality Engineer - New Product Introduction (NPI) SaniSure

LLC - 2.5

Camarillo, CA Job Details Full-time $95,000 - $105,000 a year 15 hours ago Qualifications Statistics Content creation for technical audiences Accreditation standards (regulatory compliance area) Technical documentation ISO standards Production validation processes Quality risk management Software testing Quality standards in production Design controls Biomedical regulatory compliance Technical writing within technology Cross-functional communication Full Job Description Job Summary 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. Essential Functions New Product Development Support 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 Risk Management Lead or support risk management activities per

ISO 14971

Facilitate DFMEA and PFMEA development Ensure risk controls are implemented and verified Validation & Process Qualification Support and/or lead:

IQ/OQ/PQ

activities Process validation protocols and reports Test method validation Software validation (as applicable) Ensure statistically sound validation approaches Design Transfer Ensure manufacturing readiness for product launch Review and approve: Manufacturing instructions Inspection plans Control plans Device Master Records (DMR) Support first article inspections and pilot builds Regulatory & Documentation Ensure DHF documentation completeness and compliance Support regulatory submissions (510(k), technical files, etc.) as needed Ensure labeling and packaging compliance Continuous Improvement Drive improvements in NPI processes Support CAPA investigations related to NPI activities Apply statistical tools for data-driven decision-making Sterilization Validation 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 Annual dose audits or requalification documentation Performs additional job duties as assigned. Education Bachelor's degree in biological sciences, engineering, or a related field. Required Experience & Competencies 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