Quality Assurance Specialist

4 weeks ago


Peachtree City, Georgia, United States Gerresheimer Full time
Job Description

Gerresheimer is a global leader in the development and manufacturing of pharmaceutical and cosmetic packaging solutions and drug delivery systems. We are seeking a highly skilled Quality Assurance Specialist to join our team in Peachtree City, GA.

Key Responsibilities:

  • Plan and oversee Risk Management Activities for medical devices, including A-Risk Analysis, D-DMEA, and P-FMEA, in compliance with ISO 14971.
  • Collaborate with risk management staff to conduct Risk/FMEA assessments.
  • Serve as the primary contact for customers on quality-related matters, ensuring efficient coordination and communication.
  • Define and implement Validation Strategies based on regulatory and customer requirements, following a risk-based approach, and document them in VMP and CRS/PRS.
  • Oversee validation activities, ensuring alignment with the Validation Master Plan, product specifications (CRS), and qualification/validation plans.
  • Establish and execute criteria for visual inspections of parts and assemblies during qualification and validation activities.
  • Plan and manage Product Design Verification Activities independently.
  • Define quality requirements for purchased parts and coordinate with suppliers to ensure compliance with these standards.

Requirements:

  • Technical education or equivalent qualification, such as a degree in mechanical engineering or training as a mechanical/injection molding technician, with at least 5 years of professional experience in the medical or pharmaceutical industry.
  • Extensive experience in the field of Quality Engineering or Quality Management.
  • Proficient in office software including SAP, MS Excel, MS Word, and MS PowerPoint at an advanced level.
  • In-depth knowledge of relevant standards, such as ISO 13485, ISO 15378, 21 CFR 820, and ISO 14971.
  • Strong understanding of statistical and quality management methods at a professional level.
  • Excellent analytical skills, with practical experience in systematic problem-solving techniques such as KT, Six Sigma, and Fault-Tree Analysis.


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