Supplier Quality Sterilization Specialist II

The Supplier Quality & Sterilization Specialist is responsible for managing the Stuarts Draft (SD) site sterilization activities to ensure the cleanroom is properly monitored and maintained. This role includes routine site production sterilization program investigations (when needed) and the sterilization process qualification & re-qualification maintenance activities.

The role of Supplier Quality (Engineer) supports compliance activities associated with raw materials, components, and chemicals supplied to SD.

The Supplier Quality & Sterilization Specialist will maintain proficiency in applicable standards, regulations and guidance documents to ensure compliance.

Responsibilities:

Sterility Assurance

Clean Room Qualification & Maintenance:

• Perform / Document Cleanroom Qualification (per ISO 14644-1 and ISO 14644-4).
• Establish / Document Cleanroom Area Risk Assessments (per ISO 14698, ISO 14644-2 and GPD-00106).
• Establish / Document Cleanroom & Mini-Control Area Monitoring Plans "site testing procedures" (per ISO 14698-1, ISO 14644-2, GPD-00106).
• Update Cleanroom Risk Assessments / Monitoring Plans (per ISO 14698 and ISO 14644-2).
• Perform / Document Cleanroom Re-qualification (per ISO 14644).
• Perform / Document Annual Cleanroom Review (per ISO 14644, ISO 14698).
• Perform / Document Environmental Testing to Support Planned Cleanroom Maintenance and Shutdown (per applicable site procedures).
• Trend Cleanroom & Mini-Control Area Environmental Monitoring Testing
• Perform / Document Environmental Control & Monitoring Deviations / Investigations and Perform Corrective/ Preventative Action (per GPD-00106 and site procedures).
• Perform / Document Manufacturing Site Cleanroom Training (per site procedures).
• Support Site Contamination Control Audit.
• Determine/ Lead Corrective Action Strategy associated with Site Contamination Control Audit Observations.

Sterilization Process Qualification & Re-qualification Maintenance

• Perform / Document Radiation Sterilization Dose Audits (per ISO 11137-2 and WID-00058).
• Perform / Document / Trend EO Product Bioburden Testing and Generate EO Bioburden Reports (per internal procedures).
• Perform/ Document Investigation related to EO Product Bioburden Test Limit Deviation.
• Support EO Process Re-qualifications
• Lead CAPAs and / or Investigations related to a Radiation Sterilization Dose Audit Failure or deviations.
• Support Contract Sterilizer and Test Lab Supplier Qualification Maintenance Activity

Supplier Quality

Supplier material issues management

• Reporting
• Escalation
• Supplier communication in collaboration with applicable Supply Chain/Sourcing resources
• SCAR initiation and management

Supplier Audits

• ISO-13485 Lead Auditor assessments of suppliers per the Supplier Audit Schedule and the assignments for SD.

Site supplier performance assessment

• Monitoring supplier performance for SD
• Identifying "problem" suppliers for SD

Site supplier performance reporting

• Communicating to the function and leadership on supplier performance related to SD

Supplier Quality function development

• Following and participating in Supplier Quality function changes and development
• Lessons learned, best practices
• Changes in requirements, procedures, practices, etc.
• Standardization of work

Partnering with Sourcing Specialist for overall supplier management for the site

• Supplier issue investigations
• Supplier evaluations and re-evaluations

Essential Functions of the Role**:

• Ability to travel
• Verbal and written communications, reading, and typing

Work Experience Requirements

• Number of Overall Years Necessary: 2-5
• Minimum 2-5 years of experience in quality assurance roles preferably within the medical device industry.
• Strong knowledge of global regulatory standards (FDA, ISO 13485, EU MDR, ISO 14644, ISO 14698).
• Proficiency in root cause analysis tools and statistical methods.
• Excellent communication, documentation, and project management skills.
• Ability to work independently and manage multiple priorities in a fast-paced environment.

Education Requirements

• Bachelor's Degree in scientific or engineering discipline required. Advanced Degree desired.
• Industry certifications are desirable.
• Problem Solving preferred
• Certified Quality Auditor (CQA) and/or ISO 13485 Lead Auditor preferred

Specialized Skills/Technical Knowledge:

• Strong problem-solving skills; ability to analyze all aspects of a situation, challenge current methods, identify potential solutions, make informed decisions and implement the best solution in an efficient, timely manner. Ability to apply and cultivate new approaches to problem solving
• Ability to execute strategic initiatives and manage day-to-day deliverables
• Excellent communication and negotiation skills for supplier interaction
• Ability to build, work with, and strengthen relationships with team members in other departments, other sites, outside auditors.
• Demonstrated interest in, and understanding of, industry developments and trends
• Knowledge of quality systems, regulatory requirements, and industry standards (e.g., ISO, FDA, IATF).
• Computer proficient with knowledge of SAP

Local Specifications (English and Local Language):

• English