Quality Engineer II

The anticipated salary range for this position is $70,000 -$75,000. The actual compensation offered may vary based on job related factors such as experience, skills, and education.

Job Summary

The Quality & Sterility Assurance Engineer serves as a key technical leader responsible for driving quality system excellence and ensuring robust sterility assurance across products, processes, and suppliers. This role applies engineering and scientific expertise to develop, manage, and improve validation programs—including equipment, process, software, and terminal sterilization validations. The engineer will maintain and enhance critical quality system elements such as Supplier Quality, CAPA, Document Control, Training, Risk Management, and Sterilization Standards Compliance.
The position supports new product development, change control activities, and continuous improvement initiatives while ensuring adherence to FDA QSR, ISO 13485, and international sterilization standards.

Core Responsibilities

Master Validation & Sterility Assurance Leadership

• Develop, manage, and continuously improve the Master Validation Plan, including validation protocols using strong statistical rationale, DOE, and appropriate sampling methodologies.
• Lead validation activities for equipment, processes, software, packaging aging, and terminal sterilization (EO, Gamma, E-Beam), ensuring compliance with regulatory and industry standards.
• Develop and review sterilization validation protocols, sterilization specifications, sterility assurance assessments, and contract sterilizer approval plans.
• Oversee qualification and periodic revalidation of sterilization processes and service providers.
• Provide subject matter expertise on material compatibility, microbial controls, and sterilization strategies for new products and product changes.

Quality System Ownership & Compliance

• Maintain compliance to global procedures and quality system processes, including metrics reporting, document control, training, CAPA, Supplier Quality, and Supplier Complaints.
• Manage KPIs and ensure timeliness, completeness, and quality of quality system records.
• Participate in internal and external audits of manufacturing facilities, suppliers, sterilizers, and laboratories; support audit deliverables, responses, and closure of CAPAs.
• Support global risk management practices, ensuring consistent risk assessments for product, process, and sterilization activities.
• Ensure alignment with FDA 21 CFR 820, ISO 13485, sterilization standards, and internal quality requirements.

Supplier Quality & Change Control

• Facilitate supplier quality processes through risk‑based monitoring, trending, analysis, and implementation of improvement actions.
• Manage supplier complaints including investigations, SCAR initiation, corrective action implementation, and verification of effectiveness.
• Lead or support change control deliverables related to sterilization and validation requirements.

Technical Expertise, Analysis & Continuous Improvement

• Apply Lean, Six Sigma, DOE, and problem‑solving methodologies to drive improvements in product quality, sterility assurance, and operational performance.
• Provide technical expertise for environmental monitoring requirements and sterile product manufacturing needs.
• Analyze and interpret complex data sets using tools such as Minitab, SAP, Navision, Excel, and related software.
• Participate in Quality Improvement Plans to support complaint reduction and operational quality enhancements.
• Contribute to Management Review and cross‑functional technology advancement discussions as a key technical representative.

Documentation, Training & Cross-Functional Support

• Manage the document control system, including administrative review, routing, and accuracy of quality records.
• Maintain site training programs related to document control and applicable quality system processes.
• Support R&D, Operations, Sterility Assurance, and Quality teams on new component evaluations, product design considerations, and regulatory expectations.

Qualifying Experience

Education

• Bachelor’s degree in Engineering, Microbiology, or other technical/scientific discipline is required.

Experience

• Minimum of 5 years of experience in terminal sterilization validation and sterility assurance activities.
• 6–8 years of experience in Quality Engineering or Quality Systems roles.
• Experience in a medical device or regulated manufacturing environment strongly preferred.
• Demonstrated experience in validation development, quality system management, and supplier quality.

Preferred Skills & Certifications

• Green Belt/Black Belt certification or formal Lean/Six Sigma training.
• Strong knowledge of ISO 13485, FDA QSR, sterilization standards, and medical device GMPs.
• Proficiency with Minitab and advanced Excel (including pivot tables).
• Strong analytical, communication, and leadership skills.
• Experience with DOE, risk management, problem‑solving methodologies, and technical project leadership.