Quality Engineer I - Chemistry @ STAAR Surgical - Monrovia, CA

Job Overview

2 months ago

Quality Engineer I - Chemistry

STAAR Surgical - Monrovia, CA

1. Responsible for daily lab activities including GLP compliance, compliance with safety regulations, and maintenance of appropriate levels related to lab supplies and equipment.
2. Test incoming and in-process materials, including Refractometer, FTIR and UV-Vis spectrophotometer analysis, as well as additional assigned tasks for all STAAR QC facilities.
3. Assist in development of new and improved chemical processes.
4. Assist in the preparation of samples of new materials in development which are to be used in production; oversee small-scale production of such materials.
5. Assist Manufacturing, Validation, or R&D personnel regarding technical issues related to raw materials.
6. Support site production and engineering functions in process quality improvement activities, including statistical process control, development of sampling plans, and Design of Experiments (DOE).
7. Develop receiving inspection procedures, acceptance criteria, Standard Operating Procedures, Work Instructions, and sampling plans in accordance with industry standards as required. Review relevant Quality Control procedures; generate new procedures and revise existing procedures.
8. Initiate and participate in non-conformance (NC) investigations and Corrective Action/Preventive Action (CAPA) projects regarding component failures, finished goods failures, and product returns. This includes but is not limited to performing risk analysis, determining root cause, recommending corrective action(s), implementing the plan, and submitting a summary report for project closure and conduct verification of effectiveness (VOE).
9. Participate in Design Project Teams as a QC Representative to ensure that input requirements (internal, external, and customer) are clearly defined, risk assessment is performed, output meets input requirements, and objective evidence clearly supports conclusions. Additionally, ensure that quality related issues are adequately addressed (i.e., suppliers identified and qualified, inspection activities developed, appropriate sampling plans identified, validations performed, etc.). Perform quality related design control activities as assigned by Design Project Team. Partner with production during Design Transfer phase to ensure that products and processes meet quality requirements.
10. Interface with external auditors (Notified Body, FDA, etc.) during audits at the Monrovia site; participate in the preparation and completion of corrective action plans as needed.
11. Author, participate, and complete equipment qualifications for QC Labs. Perform equipment equivalency studies.
12. Develop and validate test methods and parameters for new materials in development to ensure consistency of results. Develop technical report and method transfer.
13. Mentor and coach Quality Control personnel and develop training plans at request of management.
14. Publish summary reports, monthly progress updates and technical updates.
15. Prepare and report appropriate metrics to executive management.
16. Other duties as assigned.


  • Bachelor’s degree in Chemistry or related scientific field or equivalent combination of education/experience.
  • Advanced degree preferred.
  • Minimum 4 years experience as a chemist preferred.
  • 2 years as a quality engineer preferred.
  • Experience with laboratory instrumentation.
  • Experience in the medical device industry, including the practical application of FDA Quality System Regulation and ISO 13485 or equivalent.
  • Experience in equipment qualification and test method validations required.
  • Experience developing incoming inspection criteria using appropriate statistical methodologies preferred.
  • Demonstrated understanding of, and ability to implement, Good Manufacturing Practices
  • Demonstrated understanding of polymer chemistry and organic chemistry.
  • Ability to perform statistical analysis and plot graphs is required.
  • Demonstrated expert knowledge of Windows-based software, including Word, Excel, Access, Project, and Power Point.
  • Must be able to handle multiple projects and effectively prioritize to meet deadlines for specific projects.
  • Must be able to lift 40 pounds.

Pay range: $70k - $90k - Final compensation/salary will be depend on experience

STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.

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