Job Type
Full-time
Description
Quality EngineerFull-time | Permanent | Onsite
Salaried | $90k - $115k
*We are not accepting candidates from third party agencies.About this Opportunity:The Quality Engineer will provide support for product/process quality activities within Vantedge Medical. Areas of assignment may include: Product/Process improvement efforts, equipment validations, supplier quality performance and quality systems support.
Responsibilities:- Generate internal quality reports based on CAPA, complaints and yield. Propose and drive product/process improvement initiatives.
- Work with suppliers and Supply Chain department to improve overall performance.
- Maintain metrics to evaluate process performance and work with manufacturing to ensure that expectations are met.
- Coordinate PPQP activities (pFMEA, CP, Capability reports, GR&R etc.).
- Assist the Director of Quality in maintaining ISO 13485 QMS.
- Create/Update work instructions and procedures as needed.
- Lead and/or create equipment validation protocols and reports.
- Undertake additional responsibilities or activities as required by Director of Quality.
Requirements
- 4-year degree in Quality/Mechanical/Industrial engineering or a closely related field.
- A minimum of 2 years of work experience in a related field in a medical device or manufacturing environment.
- Understand in depth quality systems, ISO 13485 and/or 9001 standards.
- Ability to create, review, and revise operating procedures, work instructions in English.
- Specific training and demonstrated success in applying quality problem solving method, such as fishbone diagrams, 5 why, FMEA, process capability analysis, hypothesis testing, DoE, SPC, etc.
- Minitab, JMP or other statistical software capabilities.
Salary Description
$88.2 - $95.6
