Quality Engineer - Product Introduction; NPI

Quality Engineer
- New Product Introduction (NPI)

Regular
- Full Time Camarillo, CA, US

6 days ago Requisition

Salary Range: $95,000.00 To $ Annually

Sani Sure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today’s most innovative and life-changing medicines.

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.

• 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.
• 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, process validation protocols and reports, test method validation, and software validation (as applicable).
• Ensure statistically sound validation approaches.

• 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.

• 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, 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.
• Perform additional job duties as assigned.

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

• 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.

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.