Sterilization Control Assurer (12 Months fixed term)

Stryker • Arroyo, PR

1d • $69,500 - $144,200 • Hybrid

About The Position

This is a 12-month fixed-term role where the Sterilization Control Assurer is responsible for ensuring that sterilization processes are properly validated, maintained, and compliant with all applicable regulatory and quality standards. The role involves overseeing sterilization cycles, monitoring environmental controlled areas, and supporting product adoption activities while guaranteeing product sterility. The Assurer will collaborate with cross-functional teams to evaluate processes, review documentation, investigate non-conformances, and ensure that all products released meet strict regulatory requirements.

Requirements

• Bachelor’s degree in Science or related field (Biology or Microbiology preferred)
• 3–5 years of experience in Quality or Compliance within an FDA-regulated environment
• Strong knowledge of medical device regulations and standards (QSR, ISO 13485, ISO 11135, ISO 11137, ISO 14644, ISO 10993)
• Hands-on experience with sterilization validation, cycle monitoring, and cleanroom and/or EO/Gamma sterilization technologies
• Solid background in microbiology, sterility testing, and non-conformance investigations (including root cause analysis and CAPA)
• Proven experience in documentation control, batch record review, and product release within a quality system
• Experience with audits, process monitoring, trending, and continuous improvement initiatives

Nice To Haves

• Certifications or training in Sterilization, Lean Six Sigma, Lead Auditing, Risk Management, or Train-the-Trainer
• Experience acting as SME in sterilization or microbiology

Responsibilities

• Ensure compliance with sterilization control regulatory requirements for the production and release of sterile products
• Maintain full adherence to quality systems and applicable standards (e.g., QSR, ISO)
• Review and maintain documentation and procedures according to current regulatory requirements
• Monitor sterilization control systems and environmental controlled areas (ECA)
• Support batch record review and final product release processes
• Track and analyze performance metrics, trends, and audit results to identify improvement opportunities
• Evaluate changes impacting sterilization processes to ensure compliance
• Conduct investigations of non-conformances and deviations
• Recommend and implement corrective and preventive actions (CAPA)
• Support audits and ensure continuous process compliance

Benefits

• Equal opportunity employer status
• Consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level