Quality Engineer Healthcare
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Job Location:
Flowery Branch, GA - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
The Quality Engineer - Healthcare is 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
- Assist with the process of monitoring the quality system including records and results from processes and procedures to ensure product Quality and compliance.
- Supports improvement efforts within the Quality system.
- Assist with setting the standard for QA documentation review regarding quality review thoroughness and timeliness
- 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.
- Maintain knowledge of current regulatory requirements pertaining to medical device manufacturing and communicates requirements to other associate staff.
- Conducts weekly walk-throughs to ensure quality compliance
- Ensure compliance to legal and company requirements with OSHA and other health and safety regulations
- Makes recommendations to improve quality of operations
- Conducts internal audits to comply with the current ISO standards
- Lead investigations of quality issues as required. Provides analysis and trend information to support these activities.
- Participates in continuous improvement objectives to assure compliance with regulations.
- Performs other duties as assigned by management
- Maintain and apply knowledge of current policies regulations and industrial processes for Medmix USA.
- 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.
- Must have an understanding of FDA regulations i.e. 21 CFR Part 4
- Maintains quality records procedure and coordinates non-conformance reporting.
- 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.
- Assist with writing and revising quality manual regulations policies and related work instructions.
- Compiles analyze and interprets statistical data related to quality operations.
- Responsible for monitoring outside vendors to insure they are following m1edmix quality processes.
- Additional projects as assigned
Qualifications :
Work Experience: 0-2 years of experience manufacturing in a quality environment.
Education: Bachelors degree in Industrial Engineering and or Technology/Engineering
Other:
- Experience with injection molding processes parameters and troubleshooting is preferred
- Knowledge of ISO standards is a must
- 1-3 years of experience using quality management tools.
- Proficiency in the use of personal computers especially word processing software spreadsheets presentation and database software.
- Ability to learn quickly and maintain the Quality Assurance metrics.
- Knowledge of ISO standards or the ability to quickly learn and retain knowledge as required for system compliance.
- Ability to perform work accurately and thoroughly and to work independently with minimal supervision.
- Must be organized and have the ability to follow a systematic method of performing tasks and the ability to organize and direct a project to completion.
- Ensures manufacturing and quality documentation is accurate maintained and reflects GMP procedural and regulatory requirements.
- Must be self-directed and motivated to optimally utilize the available time to organize and complete expected work within given deadlines and reasonable work schedules.
- Communication skills both oral and written as required to communicate effectively with others at all levels in the organization and to provide clear and concise reports and policies as needed. Ability to effectively present information publicly.
- Ability to work well with subordinates peers and superiors in all departments.
- Ability to work onsite full time.
Additional Information :
Benefits we offer:
- An innovative vibrant and agile culture
- Growth opportunities in a globally successful and dynamic business on a growth trajectory
- Excellent employee benefits including:
- Medical dental vision Life/AD&D Short- and Long-Term Disability
- Employee Savings Plan / 401k with 100% employer match
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Revenue Cycle Management
- HIPAA
- Healthcare Management
- PMBOK
- Microsoft Outlook
- Project Leadership
- Data Management
- Project Management
- Affiliate Marketing
- Project Management Software
- Supervising Experience
- Workday
About Company
medmix es líder mundial en dispositivos de administración de alta precisión, con posiciones de liderazgo en los mercados finales de la sanidad, consumo y la industria.Nuestros clientes se benefician de nuestra orientación a la innovación y al avance tecnológico, que se ha traducido en ... View more
