Quality Engineer - Medical Device Manufacturing

POSITION PURPOSE:

The 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
3. Red Cart Process and Gemba Walk
4. Corrective and Preventive Action System (CAPA) ownership
5. Support the Equipment Qualification and Validation Process (including IQ, OQ and PQ, etc)
6. Works with Engineering to draft and execute protocols
7. Nonconforming Material System (NCMR) ownership and leads the MRB process where applicable
8. Performs First Article Inspections (FAI) with QC Personnel
9. Where applicable, creates and executes Measurement System Analysis (Gage R&R)
10. Support day to day operations to drive Key Process Indicator (KPI) improvements and business objectives
11. Supports the Approved Supplier List (ASL) Evaluations, Reporting and Feedback
12. Creates and edits Standard Operating Procedures, Work Instructions and Forms
13. Provides input to FMEAs / Risk Management
14. Performs Product Quality Inspections as needed
15. Performs Measuring and Monitoring Equipment Calibration as needed
16. Performs Training as needed
17. Perform other relevant duties as assigned by supervisor

SPECIFIC JOB KNOWLEDGE, SKILL AND ABILITY

The individual must possess the following knowledge, skills and abilities and be able to explain and demonstrate that he or she can perform the essential functions of the job, with or without reasonable accommodation.

1. Full understanding of a QMS and conformance to ISO13485
2. Nonconforming materials, calibration, corrective and preventive actions, root cause analysis, etc
3. Experience in medical component or medical device manufacturing required
4. Proficient in use of metrology (hand devices, vision systems, microscopes, non-contact devices, profilometer)
5. Basic proficiency in reading drawings, GD&T and blueprints
6. Ability to read, listen and communicate effectively in English, both verbally and in writing
7. Experience in customer, registrar or FDA audits/inspections a plus
8. Ability to navigate a computer ERP system, in certain modules, and perform data entry, data retrieval
9. Computer Skills – Microsoft Office Suite: Word, Excel, Powerpoint, Visio required (QMS software and Minitab experience a plus)
10. Willingness to continually work beyond scope of essential duties in order to assist whenever and wherever needed to ensure company needs are met

QUALIFICATION STANDARDS

Experience:

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

Education:

Bachelor’s Degree in related field

Licenses/Certifications:

Valid Class D Driver’s License.

Other:

Ability to speak Portuguese preferred