Senior Quality Engineer

Summary

At Euclid Vision Corporation, the Senior Quality Engineer will be responsible for gathering relevant information and data to solve quality-related problems, providing support and direction in Quality Assurance, Quality Control and Corrective and Preventative activities. The Sr. Quality Engineer manages quality activities related to product and process development, verification, validation, and product transfer while ensuring compliance to regulations and standards.

Essential Functions

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.  Working within the Quality Department, the Sr. Quality Engineer will be responsible for:

1. Creating, reviewing, and revising quality policies and procedures and systems to ensure compliance with ISO, regulatory and customer requirements.
2. Working with department managers to train personnel on processes and quality procedures.
3. Leading and/or participating in change control activities throughout the development, design transfer, and manufacturing processes.
4. Performing root cause analysis, preventative, and corrective actions to eliminate non-conformances. Lead cross-functional project teams in areas of continuous improvement, non-conformances, Issue Review (IR) and CAPAs.
5. Performing Corrective and Preventive Actions (CAPA activities coordination.
6. Supporting site production and engineering functions in process quality improvement activities.
7. Reviewing, updating, and approving software, equipment, process and test method validation protocols and reports
8. Applying statistical methods of analysis and process control to current operations in support of management review, CAPA, and other quality system processes.
9. Applying risk management practices and concepts to manufacturing operations.
10. Leading quality system projects of a varying scope and complexity.
11. Supporting the development of manufacturing processes for new and existing products and manufacturing transfers to/from other plants/facilities.
12. Initiating CAPA Risk Assessments, timely review and approval of NCs and CAPAs ensuring completeness, accuracy, and effectivity.
13. Facilitating and guiding cross-functional teams through all stages of the NC / CAPA process.
14. Implementing and executing CAPA Review Board forums.
15. Establishing site KPIs and monitoring KPIs to ensure compliance to global requirements and to ensure metrics are achieved and provide detailed updates to management.
16. Monitoring customer feedback, complaints, process non-conformances, and surveillance audits and identify opportunities for continuous improvement.
17. Participating in cross-functional project teams in areas of continuous improvement, non-conformances, complaints, and CAPAs.
18. SME in internal and third-party compliance audits.

Qualifications

1. S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE)
2. 5-7 years’ experience in a Quality Engineering role; Medical device strongly preferred.
3. Ability to communicate effectively (both written and verbal)­ with various levels within the organization.
4. Hands on experience delivering timely and accurate QMS documents.
5. Hands-on experience working through all phases of the CAPA process.
6. Knowledgeable in GMP, GDP, ISO 13485, and 21 CFR 820 requirements.
7. Experience in supporting Quality Systems (e.g. Audits, Management review, Quality Planning).
8. Exceptional organizational skills include the ability to handle multiple assignments and prioritize work.
9. Developed problem solving skills and analytical skills required.
10. Professional certification in a quality subject matter (e.g., MS, CQE, CQA, Six Sigma), preferred.
11. Knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment, preferred.
12. Project management skills and ability to influence without authority.
13. Demonstrated ability to work independently.