Costa Rica Job Openings
MicroVention, Inc.
Technician II, Quality Reliability - CR
October 30, 2024
- Ensure conformance to quality systems with respect to internal procedures and applicable Quality Systems Regulations.
- Perform Bacterial Endotoxin sampling and testing.
- Perform and support clean room monitoring and validation activities, including, but not limited to, microbial, particulate, and pressure differential testing.
- Coordinate microbiological testing performed in-house and by outside laboratories to support routine and validation studies.
- Support technical justifications and physical studies for adoption of new products into existing sterilization cycles, including, but not limited to, sterilization validation, endotoxin level testing (LAL), product bioburden testing, and residual testing.
- Perform complex mechanical, dimensional, and microbial assessments on raw materials or products/subassemblies and finished goods.
- Provide guidance on sterilization control and sterile load release function.
- Support Quality Reliability Engineering and Operations regarding validations and transfers projects.
- Provide support with non-conformance investigations and correction implementation as required.
- Perform documents updates as necessary.
- Support Quality Reliability Engineering and Operations in the development and execution of internal test methods and validations.
- Provide leadership and training to the QC, Production Operators and RI inspectors.
- Notify Quality Engineering in the event of a nonconformance or noncompliance situation.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
Job Details
- Minimum of three (3) years of quality/microbiology/sterilization experience in the medical device industry.
- Advanced or completed studies as a quality technician, laboratory technician, microbiology technician, or equivalent.
- Knowledge of laboratory techniques and use of equipment.
- Ability to follow company, quality and regulatory procedures and standards.
- Strong written and verbal communication skills.
- Proficient at MS Windows and Office.
- Strong organizational and interpersonal skills. Ability to manage several tasks and projects.
- Ability to work independently with little supervision.
- Knowledge of basic statistical tools and software and concepts a plus.
- Knowledge of ANSI/AAMI/ISO 11135 and BS/EN/ISO 11137.
- Knowledge of Cleanroom controls and monitoring and pyrogen testing processes.
- Basic knowledge of QSR (CFR 21 820 and ISO 13485).
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