Job Description

CooperSurgical is a globally provider of more than 600 products, each with a focus on improving the health of women, babies and families additionally is a Premier Provider of Medical Devices, Fertility and Genomics Solutions.

You will have a paramount role in the team and have responsibilities for writing protocols, executing and reporting on performed qualifications and process validations for a brand new and state-of-the-art manufacturing facility in Alajuela, Costa Rica. It is expected that you become very familiar with all QC equipment and processes so you can provide technical supervision and troubleshooting assistance to QC technicians during method validations and routine testing

1. Sets up, plans and executes qualification and validation activities and assures adherence to timeline and validation schedule. This involves protocol and report writing as well as actual execution of the qualifications/validations together with technicians for all the analytical equipment for the QC lab.

2. Plans, designs, develops and executes testing activities for laboratory test method development and validation.

3. Responsible for the management and maintenance of lab equipment; including establishing and managing maintenance contracts, tracking and coordinating maintenance and calibrations, scheduling repairs and maintaining a laboratory matrix and asset tagging.

4. Performs troubleshooting and root cause analysis together with a team of technicians and manager on equipment and processes not conforming to specifications.

5. Oversees equipment’s alarm process and respond and resolve any equipment alarms and notify appropriate members when necessary.

6. Monitors and keeps trends of laboratory testing.

7. Works cross-functionally in identifying and resolving technical issues.

8. Reviews and approves laboratory results final reports for production and raw material release.

9. Acquires skills and knowledge necessary to develop and validate analytical methods.

10. Cooperates within Management and the Quality department with audit site readiness and to be in compliance with Corporate and applicable regulations.

11. Collaborates with manufacturing engineering to ensure all quality control equipment and methods are adequately transferred from sending sites and implemented in production (in process controls) and/or in quality control lab (finished product testing).

12. Assists Management integrating necessary SOP's in existing quality management system.

13. Conducts laboratory investigations which may include OOS, NCMR, CAPA, out of tolerance and Environmental monitoring out of alert/action.

14. Complies with GMP, ISO, FDA and OSHA regulations.

15. Performs other tasks as directed by management.

1. Degree in biomedical engineering, engineering in bioprocesses, biotechnology, microbiology, chemical engineering or similar.
2. A minimum of 3 years of experience with quality control and equipment qualification and method validation (IQ, OQ, PQ) in Medical Devices industry.
3. Understanding of equipment troubleshooting, equipment qualification and analytical method validation. Experience with pH, osmolality, ELISA, Viscosity, Density, RP-HPLC and sterility testing is an advantage.
4. Understanding of aseptic manufacturing or pharmaceutical manufacturing is preferred.
5. Ability to solve practical problems and generate creative solutions
6. Ability to communicate well in English, both orally and written.
7. Skilled with MS Word, Excel, Power Point, and other programs like Minitab. Ability to work with mathematical concepts such as statistics and probability.
8. Hands on attitude, good communication and negotiation skills with internal customers, sub-contractors, suppliers and manufacturers
9. Thorough understanding of medical device manufacturing, especially as it relates to FDA (GMP) manufacturing requirements