Quality Engineer

Required Qualifications

• Bachelor's Degree, in Engineering.

• Minimum 2 years of experience. Relevant experience in Quality and/or Compliance, preferably in medical device industry.

• Knowledge of applicable US non-US applicable regulations.

• Knowledge and proficiency in the application and principles of Quality Engineering.

• Ability to effectively communicate cross-functionally to assist with resolving Quality issues.

• Excellent written, verbal and interpersonal communication skills in both English and Spanish.

• Ability to interact effectively with all levels of employees.

• Digital skills. Microsoft Office.

1. 1

   Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

2. 2

   Identifies manufacturing process defects (scrap, nonconforming material, customer complaints), dispositions non-conforming material, leads identification of primary root causes for basic investigations, identifies appropriate corrective and preventive actions.

3. 3

   Supports line support team (QC Supervisor, Mfg Supervisor, Quality Engineer and Operations) to perform line situation triage and determine if non-conformance is present, determine initial bracketing and containment, and initiate exception management process.

4. 4

   Owns basic to moderate exception / CAPA activities without oversight. May be responsible for working with process owner to bound product stops and document release criteria.

5. 5

   Can perform lot to lot yield and rework evaluation. May be responsible for reporting of quality metrics.

6. 6

   Understands product quality plans, documents, and quality systems.

7. 7

   Develops product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.

8. 8

   May be responsible for owning and maintaining product risk analyses and FMEAs. Monitors process by using process monitoring tools and Infinity QS to reduce process variation.

9. 9

   Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development.

10. 10

    Understands Quality Tools & Training Materials and helps others in gaining knowledge of prevalent tools used and available training materials.

11. 11

    Can lead Product/Process improvement efforts (e.g). scrap, nonconforming product, customer complains) by systematically gathering quality metric data and by using appropriate analysis methods to enhance sustaining product design.

12. 12

    Runs routine problem-solving investigation without oversight and use of six Sigma tools.

13. 13

    Implements minor and major changes through change management system and provides quality engineering impact assessment for changes implemented by other functional areas.

14. 14

    May write protocols and reports with management oversight to support engineering studies and validations.

1. 15

   May write protocols and reports with management oversight to support engineering studies and validations.

1. 16

   May write and /or approve protocols and reports with management oversight to support engineering studies and validations.