Quality Engineer

medmix•Flowery Branch, GA

2d•Hybrid

About The Position

Our manufacturing site in Flowery Branch Georgia is actively searching a Quality Engineer. This position will be 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.

Requirements

1-3 years of experience manufacturing in a quality environment.
Bachelor’s degree in Industrial Engineering and or Technology/Engineering
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 and/or documented 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.

Nice To Haves

Experience with injection molding processes, parameters, and troubleshooting is preferred

Responsibilities

Assist in monitoring the Quality System, including review of records and process results, to ensure product quality and regulatory compliance.
Support continuous improvement efforts within the Quality System.
Maintain knowledge of current regulatory requirements for medical device manufacturing and combination product manufacturing and communicate key requirements to staff.
Ensure manufacturing and quality documentation is accurate, controlled, and compliant with GMP, internal procedures, and regulatory standards.
Conduct weekly quality walk‑throughs to assess compliance and identify improvement opportunities.
Ensure compliance with OSHA and other applicable health and safety regulations.
Conduct internal audits in accordance with current ISO standards and FDA regulations.
Administer and maintain the ISO Quality System, including certification renewals, quality manuals, quality records, process maps, and work instructions.
Understand and apply relevant FDA regulations (e.g., 21 CFR Part 4).
Maintain and apply knowledge of company policies, regulations, and industrial processes
Maintain quality records procedures and support the nonconformance reporting process.
Review and approve nonconformance reports; coordinate cross‑department follow‑up; calculate cost of quality; and identify trends or significant issues for management escalation.
Lead investigations of quality issues as required, using structured root‑cause analysis techniques.
Provide analysis and trending data to support issue investigations and CAPA activities.
Collaborate cross‑functionally to address containment actions and implement corrective actions.
Conduct risk assessments using tools such as PFMEA.
Assist in setting standards for thorough and timely QA documentation review.
Provide constructive feedback to QA and Operations personnel regarding documentation quality.
Write and revise quality manuals, procedures, policies, and related work instructions.
Participate in continuous improvement initiatives to maintain regulatory compliance and improve operational quality.
Recommend enhancements to improve quality performance and operational efficiency.
Perform other duties and additional projects as assigned by management.

Benefits

An innovative, vibrant and agile culture
Growth opportunities in a globally successful and dynamic business on a growth trajectory
Up to three (3) weeks of paid time off beginning your first year
Twelve (12) company paid holidays per year
Medical, dental, vision, Life/AD&D, Short- and Long-Term Disability, Identity Theft and Legal Protection plan options
medmix Employee Savings Plan / 401k with 100% employer match up to 6% of your annual base salary
Eligible to receive additional non-elective 401k contributions on a quarterly basis
Health Savings Account with dollar-for-dollar matching based on coverage level
Employee Assistance, Health and Wellness Program
Flexible working hours and hybrid on-site/home office model
Access to a wide range of discounts on shopping, entertainment and lifestyle