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Sterilization Control Assurer (12 Months fixed term)
Arroyo, Puerto RicoPosted 3 days ago
Full-timeonsite
Job Description
Work Flexibility: Hybrid
What you will do
As a Sterilization Control Assurer, you will be responsible for ensuring that sterilization processes are properly validated, maintained, and compliant with all applicable regulatory and quality standards. You will oversee sterilization cycles, monitor environmental controlled areas, and support product adoption activities while guaranteeing product sterility. Additionally, you will work closely with cross-functional teams to evaluate processes, review documentation, investigate non-conformances, and ensure that all products released meet strict regulatory requirements.
Main 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
What you need
Required:
- 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
Preferred:
- Certifications or training in Sterilization, Lean Six Sigma, Lead Auditing, Risk Management, or Train-the-Trainer; experience acting as SME in sterilization or microbiology
United States of America Pay Ranges:
- USN: $69,500 - $110,900 USD Annual
- Puerto Rico: $69,500 - $110,900 USD Annual
- US5: $73,000 - $116,400 USD Annual
- US10: $76,500 - $122,000 USD Annual
- US15: $79,900 - $127,500 USD Annual
- US20: $83,400 - $133,100 USD Annual
- US30: $90,400 - $144,200 USD Annual
Travel Percentage: NoneStryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.