Quality Engineer - Healthcare at medmix

Flowery Branch, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Feb, 26

Salary

0.0

Posted On

20 Nov, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Regulatory Compliance, Documentation Review, Internal Audits, Statistical Analysis, Injection Molding, ISO Standards, GMP, Communication, Problem Solving, Continuous Improvement, Quality Assurance, Self-Motivation, Organization, Team Collaboration, Time Management

Industry

Medical Device

Description

Company Description We are searching for a Quality Engineer - Healthcare to join us at our growing manufacturing site in Flowery Branch, Georgia. This exciting opportunity will allow you to 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 us to the next level. Job Description 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: Bachelor’s 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

Responsibilities

The Quality Engineer - Healthcare is responsible for assisting with the implementation and management of the quality management system to ensure compliance with quality and regulatory requirements. This role includes conducting audits, leading investigations of quality issues, and making recommendations for operational improvements.