The Senior Quality Engineer is responsible for supporting the effectiveness of the Quality Management System (QMS) and to ensure compliance of QMS activities to

ISO13485

2016. Partner with management team to ensure adherence to the QMS. Provide consistent product and process support for shop floor manufacturing to ensure maximized uptime and high product quality is achieved.

ESSENTIAL FUNCTIONS

- The following list of essential job functions is not exhaustive and may be supplemented as necessary based on business needs. 1. Supports the maintenance of the QMS ensuring its continuing suitability, adequacy and effectiveness 2. Shop floor support for troubleshooting, root cause analysis, support production uptime with engineering a. Red Cart Process and Gemba Walk 3. Corrective and Preventive Action System (CAPA) ownership 4. Support the Equipment Qualification and Validation Process (including IQ, OQ and PQ, etc) a. Works with Engineering to draft and execute protocols 5. Nonconforming Material System (NCMR) ownership and leads the MRB process where applicable 6. Performs First Article Inspections (FAI) with QC Personnel 7. Where applicable, creates and executes Measurement System Analysis (Gage R&R) 8. Support day to day operations to drive Key Process Indicator (KPI) improvements and business objectives 9. Supports the Approved Supplier List (ASL) Evaluations, Reporting and Feedback 10. Creates and edits Standard Operating Procedures, Work Instructions and Forms 11. Provides input to FMEAs / Risk Management 12. Performs Product Quality Inspections as needed 13. Performs Measuring and Monitoring Equipment Calibration as needed 14. Performs Training as needed 15. Perform other relevant duties as assigned by supervisor

QUALIFICATION STANDARDS

Experience:

5 to 7 years of related experience in quality engineering in medical device or medical components required

Education:

Bachelor's Degree in related field

Licenses/Certifications:

Valid Class D Driver's License.

Other:

Ability to speak Portuguese preferred

Pay:

$115,000.00 - $120,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Health savings account Life insurance Paid time off Vision insurance Application Question(s): Please describe your experience in medical manufacturing Please describe your experience with problem solving and root cause analysis Tell us about what measuring devices you have used Do you have familiarity with ISO13485 and in what capacity What is your availability for a Teams screening interview What is your email address

Work Location:

In person