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QA Sterilization Assurance Scientist Job
Date: May 5, 2012
Location: Phoenix, AZ, US
Requisition ID: 18526BR
Job Title: QA Sterilization Assurance Scientist
Division: Stryker Sustainability Solutions
Business Functions: Quality Assurance Safety
Focus Area Production Quality Assurance
Country: United States
State: AZ
City: Phoenix
Shift: 1st
Job Description:
The Quality Assurance Sterilization Assurance Scientist is responsible for assuring the quality and sterility integrity of medical devices through testing, validation, and analysis of processes and systems.
Qualifications/Work Experience: - Minimum 5 years sterilization/ microbiological experience in the medical device industry. Biocompatibility knowledge and experience a plus.
- Provides guidance and technical support to customers (e.g. QA, Operations, Facilities, Regulatory Affairs, R&D, laboratories, external customers) related to clean room practices, auditing, cost improvement projects (CIPs), biological/chemical testing, sterilization and Biocompatibility.
- Drafts and executes validations pertaining to sterilization of medical devices in accordance with ISO, AAMI, and other industry standards and guidelines.
- Ensures sterilization validations (i.e. dose audits, EO validations, etc) for all product families are maintained.
- Drafts sterilization validation protocols and reports to ensure the appropriate regulatory requirements are met.
- Works with customers to ensure timely and complete sterilization adoptions and validations of all new/changed products.
- Provides guidance and methodologies to cover all SA programs related to LAL, bioburden, and environmental monitoring.
- Maintains knowledge of FDA & ISO sterilization and device reprocessing guidelines.
- Conducts technical assessments of contract sterilizers and laboratories.
- Provides input on the resolution of sterility related non-conformances and product dispositions.
- Assists in the preparation and response to regulatory submissions on the following subjects: sterilization, biocompatibility, and manufacturing environment monitoring.
- Provides assistance and knowledge during regulatory/compliance body audits (FDA, ISO, etc.).
- Demonstrated scientific writing skills and excellent verbal communication skills.
- Project Management or basic supervisory skills preferred.
- Ability to work in a team environment and multi-task under stressful circumstances.
- Other duties/responsibilities as assigned by manager.
Education and/or Special Training: - BS Degree in Microbiology, Biological Sciences or Engineering.
- Well versed in government regulations and industry guidelines for sterilization (i.e. ISO/EN/AAMI/USP standards) and microbiological control of medical devices
Percent Travel Required: 0
Job Title: QA Sterilization Assurance Scientist
Division: Stryker Sustainability Solutions
Business Functions: Quality Assurance Safety
Focus Area Production Quality Assurance
Country: United States
State: AZ
City: Phoenix
Shift: 1st
Job Description:
The Quality Assurance Sterilization Assurance Scientist is responsible for assuring the quality and sterility integrity of medical devices through testing, validation, and analysis of processes and systems.
Qualifications/Work Experience: - Minimum 5 years sterilization/ microbiological experience in the medical device industry. Biocompatibility knowledge and experience a plus.
- Provides guidance and technical support to customers (e.g. QA, Operations, Facilities, Regulatory Affairs, R&D, laboratories, external customers) related to clean room practices, auditing, cost improvement projects (CIPs), biological/chemical testing, sterilization and Biocompatibility.
- Drafts and executes validations pertaining to sterilization of medical devices in accordance with ISO, AAMI, and other industry standards and guidelines.
- Ensures sterilization validations (i.e. dose audits, EO validations, etc) for all product families are maintained.
- Drafts sterilization validation protocols and reports to ensure the appropriate regulatory requirements are met.
- Works with customers to ensure timely and complete sterilization adoptions and validations of all new/changed products.
- Provides guidance and methodologies to cover all SA programs related to LAL, bioburden, and environmental monitoring.
- Maintains knowledge of FDA & ISO sterilization and device reprocessing guidelines.
- Conducts technical assessments of contract sterilizers and laboratories.
- Provides input on the resolution of sterility related non-conformances and product dispositions.
- Assists in the preparation and response to regulatory submissions on the following subjects: sterilization, biocompatibility, and manufacturing environment monitoring.
- Provides assistance and knowledge during regulatory/compliance body audits (FDA, ISO, etc.).
- Demonstrated scientific writing skills and excellent verbal communication skills.
- Project Management or basic supervisory skills preferred.
- Ability to work in a team environment and multi-task under stressful circumstances.
- Other duties/responsibilities as assigned by manager.
Education and/or Special Training: - BS Degree in Microbiology, Biological Sciences or Engineering.
- Well versed in government regulations and industry guidelines for sterilization (i.e. ISO/EN/AAMI/USP standards) and microbiological control of medical devices
Percent Travel Required: 0
Nearest Major Market: Phoenix
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