Quality Specialist

Reposted Yesterday
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Flowery Branch, GA, USA
In-Office
Mid level
Healthtech
The Role
Maintain and administer the QMS, support complaint investigations and corrective actions, perform ISO 9001 internal audits, track and report QMS metrics and KPIs, liaise between operations, supply chain and design, and support customer-facing quality communications and reporting.
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

Job purpose

The Quality Specialist plays a critical role in maintaining the integrity of the organization’s quality management system and documentation processes, while actively supporting the operations team, customer and sales teams. This position ensures that all documentation meets regulatory, contractual, and internal standards, and facilitates timely access to accurate information for both internal stakeholders and external customers. By collaborating with sales and operations team, the specialist helps address client inquiries, supports quality-related communications, and ensures that customer-facing documentation reflects the highest standards of accuracy and professionalism.

 

Main accountabilities and tasks

  1. Coordinate information gathering and communication for quality complaint. Support local and global nonconformance investigations of internal and external product complaints
  2. Leads and participates in formal problem-solving, including formal reporting for internal and external customers
  3. Internal auditing of ISO 9001 Quality Management System and serve as Management Representative to the Quality System Registrar
  4. Track key metrics and report on the performance of the QMS (e.g., results of quality audits, corrective actions), including root cause and counter measures
  5. Serves as a quality liaison between supply chain, operations, and design authority when quality problems exist that affect product quality and customers
  6. Work directly with Operations management to establish and monitor quality metrics and ensure the metrics are achieved
  7. Prepare and reports activity updates for management to keep them apprised of quality initiatives and concerns
  8. Tracks local and global KPI’s and reports weekly/monthly as needed

Qualifications

Work experience:  3-5 years of experience in a Quality Assurance role focusing on ISO 9001 compliance standards and internal auditing methods

 Experience working in a customer-facing environment, preferably in industrial manufacturing.

Education:  Associate’s or Bachelor’s degree preferred.

Other:

  1. Certifications an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma
  2. Quality inspection, auditing and testing experience, ISO 9001, 14001, 45001
  3. Experience with implementation of corrective action programs
  4. Product or industry-specific experience preferred
  5. Strong computer skills including Microsoft Office, QA applications and databases
  6. Knowledge of tools, concepts, and methodologies of QA
  7. Solid experience in effective usage of data analysis tools and statistical analysis
  8. Knowledge of relevant regulatory requirements, local and state

 

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
Databases
Iso 14001
Iso 45001
Iso 9001
MS Office
Qa Applications
Six Sigma
Statistical Analysis
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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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