Quality and Documentation Specialist

Posted 4 Days Ago
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Flowery Branch, GA, USA
In-Office
Mid level
Healthtech
The Role
The Quality and Documentation Specialist will manage quality management systems, conduct audits, track performance metrics, and liaise with multiple teams to ensure compliance and resolve quality issues.
Summary Generated by Built In
Company Description

Medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from our dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 14 production sites worldwide, together with our highly motivated and experienced team of nearly 2’600 employees provide our customers with uncompromising quality, proximity, and agility. Medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX). www.medmix.swiss

As Quality and Documentation Specialist (Industry/Dental) you will be responsible for assisting with the implementation, management, and administration of the quality management system and ensuring products are manufactured per quality, regulatory requirements and industry best practices. You will be part of a team of over ten quality experts at our Flowery Branch (Georgia - GA) facility.

Job Description

  • Coordinate information gathering, communication, and documentation related to quality complaints and nonconformance investigations
  • Support local and global investigations of internal and external product issues, including formal problem‑solving and reporting
  • Serve as an internal auditor for the ISO 9001 Quality Management System and act as the Management Representative to the Quality System Registrar
  • Track and report on QMS performance metrics, including audit results, corrective actions, root causes, and countermeasures
  • Act as a liaison between Supply Chain, Operations, and Design Authority to resolve quality issues impacting products and customers
  • Work with Operations management to establish, monitor, and achieve key quality metrics
  • Prepare and deliver regular activity and performance updates to management regarding quality initiatives and concerns
  • Monitor and report on local and global KPIs on weekly/monthly cycles as required
  • Ensure accuracy, compliance, and consistency of all quality‑related documentation, including customer‑facing materials
  • Collaborate with Operations, Sales, and Customer teams to provide timely responses to client inquiries and ensure professional communication

Qualifications

  • Associate’s or Bachelor’s degree in an industry related subject
  • Several years of experience in a Quality Assurance role within industrial manufacturing and a customer-facing environment
  • Work experience on ISO 9001 compliance standards and internal auditing methods
  • Knowledge of relevant regulatory requirements, local and state
  • Solid experience in effective usage of data analysis tools and statistical analysis 
  • Knowledge on ISO 14001, 45001
  • Experience with implementation of corrective action programs
  • Certifications as e.g. Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma are an advantage
  • Strong computer skills including Microsoft Office, QA applications and databases

Physical requirements

In order to perform the essential functions of this position, with or without reasonable accommodations, the employee must be able to see, hear, talk, and use hands and fingers to operate computer hardware and peripherals. Employee must be able to lift up to 25lbs. on an occasional basis. 

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

Top Skills

Data Analysis Tools
Iso 14001
Iso 45001
Iso 9001
MS Office
Qa Applications
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The Company
HQ: Zug CH
802 Employees

What We Do

medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer and industrial end-markets. Our customers benefit from a dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 15 production sites worldwide together with our highly motivated and experienced team of over 1’900 employees provide our customers with uncompromising quality, proximity and agility. medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX). www.medmix.swiss

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