Quality Engineer

Company Description

At medmix, our team is focused on a single mission, to provide innovative solutions that help millions of people live healthier and more confident lives. Join us to expand your career opportunities in a high growth business, where your unique skills are valued.  

We are looking for a Quality Engineer to join us at medmix. This exciting opportunity will allow you use your skills to identify areas of improvement and propose recommendations to management. You will lead and drive the implementation of your recommendations and assess its impact to the business. If you are eager to learn, strive for personal development, are highly motivated and organized, and a great communicator, you can help us drive medmix to the next level.  

Job Description

Job purpose

Responsible for assisting with the implementation, management, and administration of the quality management system and ensuring products are manufactured per quality and regulatory requirements and industry best practices.                                                                                                                                                         

Main Accountabilities and tasks

1. Assist with the process of monitoring the quality system including records and results from processes and procedures to ensure product Quality and compliance.
2. Assist with setting the standard for QA documentation review regarding quality review thoroughness and timeliness
3. Ensures manufacturing and quality documentation is accurate, maintained, and reflects GMP, procedural and regulatory requirements.  Provides constructive feedback to QA and Operations staff regarding documentation quality. 
4. Maintain knowledge of current regulatory requirements pertaining to medical device manufacturing and communicates requirements to other associate staff. 
5. Conducts weekly walk-throughs to ensure quality compliance
6. Ensure compliance to legal and company requirements with OSHA and other health and safety regulations
7. Makes recommendations to improve quality of operations
8. Conducts internal audits to comply with the current ISO standards
9. Lead investigations of quality issues as required.  Provides analysis and trend information to support these activities.
10. Participates in continuous improvement objectives to assure compliance with regulations.
11. Performs other duties as assigned by management
12. Maintain and apply knowledge of current policies, regulations, and industrial processes for Medmix USA.
13. Responsible for administration of and compliance with the ISO quality system and for administration as required to maintain and renew the certification upon expiration; for coordinating revisions to or required upgrades for the quality system; and for maintaining required Quality Manual, all quality records, process maps and work instructions for the location in Oakwood, GA.
14. Maintains quality records procedure and coordinates non-conformance reporting.
15. Reviews and approves non-conformance reports and responds, calculates related cost of quality, coordinates cross-department issues, notifies managers and management team of trends or significant issues.
16. Assist with writing and revising quality manual, regulations, policies, and related work instructions.
17. Compiles, analyze, and interprets statistical data related to quality operations.
18. Responsible for monitoring outside vendors to insure they are following Medmix quality processes.
19. Additional projects as assigned

Qualifications

Work Experience: 0-2 years of experience manufacturing in a quality environment.

Education: Bachelor’s degree in Industrial Engineering and or Technology/Engineering

Other:

1. Experience with injection molding processes, parameters, and troubleshooting is preferred
2. Knowledge of ISO standards is a must
3. 0-2 years of experience using quality management tools.
4. Experience in developing and conducting employee training programs is preferred
5. Qualification/Certification as an Internal Auditor preferred
6. Proficiency in the use of personal computers, especially word processing software, spreadsheets, presentation, and database software.
7. Ability to learn quickly and maintain the Quality Assurance metrics.
8. Knowledge of ISO standards or the ability to quickly learn and retain knowledge as required for system compliance.
9. Ability to perform work accurately and thoroughly and to work independently with minimal supervision.  
10. Must be organized and have the ability to follow a systematic method of performing tasks and the ability to organize and direct a projec