Easter Seals Jobs

12228BR

Title:

Technician II, Quality Reliability - CR

Job Description:

The Quality Technician II provides integral support to the quality reliability team by ensuring finished products meet the established quality standards and world-wide regulatory requirements. This position requires the ability to handle the completion of a diverse set of projects and tasks.

Job duties:

1. 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

2. Performs Bacterial Endotoxin sampling and testing.

3. Perform and support clean room monitoring and validation activities, including, but not limited to, microbial, particulate, and pressure differential testing.

4. Coordinate microbiological testing performed in-house and by outside laboratories, to support routine and validation studies.

5. 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.

6. Performs complex mechanical, dimensional, microbial assessments on raw materials, or products/subassemblies and finished goods.

7. Provide guidance on sterilization control and sterile load release function.

8. Supports Quality Reliability Engineering and Operations regarding validations and transfers projects.

9. Provides support on non-conformance investigation and correction implementation as required.

10. Perform documents updates as necessary.

11. Supports Quality Reliability Engineering and Operations in the development and execution of internal test methods, and validations.

12. Provides leadership and training to the QC, Production Operators and RI inspectors.

13. Notifies Quality Engineering in the event of a nonconformance, noncompliance situation.

14. Perform additional duties, as assigned

Auto req ID:

12228BR

Location:

Alajuela, Costa Rica

Department Name:

3211-CR-Quality

Qualifications:

Required Qualifications:

1. At least three (3) years of quality/microbiology/sterilization experience in the medical device industry.

2. Completed studies as a quality technician, laboratory technician, microbiology technician or equivalent.

3. Knowledge of laboratory techniques and use of equipment.

4. Ability to follow company, quality and regulatory procedures and standards.

Desired Qualifications:

1. Good communication, written, organizational and interpersonal skills. Ability to manage several tasks and projects.

2. Ability to work independently with little supervision.

3. Proficient at MS Windows and MS Office.

4. Knowledge of basic statistical tools and software and concepts a plus.

5. Knowledge of ANSI/AAMI/ISO 11135 and BS/EN/ISO 11137.

6. Knowledge of Cleanroom controls and monitoring and pyrogen testing processes.

7. Basic knowledge of QSR (CFR 21 820 and ISO 13485).

External-Facing Title:

Technician II, Quality Reliability - CR

Posting Country:

Outside US

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.