Sterilization Quality Assurance Process Engineer

Clutch Canada; Parsippany-Troy Hills (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Onkos Surgical is seeking a QA Process Control Engineer in New Jersey to ensure sterilization and microbiological testing meet top regulatory and quality standards. You will manage sterilization cycle validations, maintenance, and product release procedures related to cleaning and sterilization.

You will collaborate with Product Development and cross-functional teams to validate cleaning protocols for new products while upholding quality systems and policies governing controlled environments and

Qualifications

• Minimum of 5 years' experience in cleaning and sterilization in medical manufacturing or pharmaceutical industry.
• Strong knowledge of microbiological testing and sterilization cycle validations.
• Experience with environmental monitoring and sterility tests.
• Familiar with FDA, USP, ISO standards and ISO 13485.
• Proficient in sterilization modalities: ethylene oxide, gamma, and steam.

Responsibilities

• Regulatory & Quality Compliance: ensure adherence to regulatory and quality system requirements for cleaning and sterilization.
• Sterilization Controls: oversee validations, cycle maintenance and evaluations to guarantee sterility and compliance.
• New Product Initiation & Validation: validate and adopt cleaning protocols and sterilization processes for product launches with cross-functional teams.
• Documentation & Auditing: maintain documentation for sterilization processes, controlled environments, and release procedures; monitor via monthly reports and audits.
• Risk Management & Investigations: perform risk assessments, conduct non-conformance investigations, lead CAPA projects.
• Process Development: define and implement sterility assurance procedures and environmental controls; support policy maintenance.
• Authority & Decision-Making: recommend and initiate preventive and corrective actions for non-conformance.

Skills

Sterilization expertise

Microbiological testing

Regulatory compliance

Process validation

Environmental monitoring

ISO 13485 familiarity

Job description

Onkos Surgical is seeking a QA Process Control Engineer in New Jersey to ensure sterilization and microbiological testing meet top regulatory and quality standards. You will manage sterilization cycle validations, maintenance, and product release procedures related to cleaning and sterilization.

You will collaborate with Product Development and cross-functional teams to validate cleaning protocols for new products while upholding quality systems and policies governing controlled environments and