Quality Engineer - Design Quality Assurance & Sterilization

SaniSure; Camarillo (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

SaniSure in Camarillo, California is seeking an NPI Quality Engineer to ensure quality and regulatory compliance during new product development. The role involves cross-functional collaboration and responsibilities for design validation and manufacturing readiness.

The ideal candidate will hold a Bachelor’s degree in a relevant field and have at least 3 years of experience in medical device quality engineering, alongside strong documentation skills and knowledge of FDA regulations.

Qualifications

• Minimum 3 years of experience in medical device quality engineering.
• Experience with FDA 21 CFR Part 820 (QSR), ISO 13485, and Design Controls.
• Strong technical documentation skills.

Responsibilities

• Ensure compliance with regulatory requirements during product development.
• Drive improvements in NPI processes and support CAPA investigations.
• Lead or support risk management activities per ISO 14971.

Skills

Quality engineering

Regulatory compliance

Statistical analysis

Cross-functional teamwork

Education

Bachelor’s degree in biological sciences, engineering, or a related field

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, and 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, and 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, and 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, and Steam sterilization (as applicable).
• Ensure compliance with relevant standards including ISO 11135 (EO), ISO 11137 (Radiation), and 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, and load configuration qualification.
• Review and approve sterilization validation reports, annual dose audits, and requalification documentation.

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), and process validation.
• Strong knowledge of validation methodologies and statistical analysis.
• Experience participating in cross‑functional development teams.
• Strong technical documentation skills.

Equal Employment Opportunity Policy

We are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion (including religious dress and grooming practices), color, sex (including childbirth, breast feeding, and related medical conditions), gender identity or expression, sexual orientation, national origin, citizenship status, uniform service member status, pregnancy, age (40 and over), genetic information, disability (mental and physical), or any other protected status in accordance with all applicable federal, state, and local laws.