Gerresheimer
Customer Quality Engineer
Peachtree City, Georgia, United States
Sponsorship not specifiedDetected 1 day ago
TypeScriptStatisticsProduct ManagementSupply ChainProcess ImprovementERPMechanical DesignMedical DevicesCommunicationProblem SolvingPublic SpeakingMicrosoft OfficeLean Manufacturing
> stay_score
odds of building a lasting career here
25Risky
Cap-exempt (no lottery)0
Sponsors this role35
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →> community_outcomes
No reports yet — be the first to help the next applicant.
About the role
- Solid professional experience in the field of Quality for at least 5 years.
Responsibilities
- Perform review and approval of validations, qualifications and certificates of analysis.
- Independently evaluate, process, and implement change requests using formal change control processes, ensuring appropriate risk assessment, cross-functional alignment, documentation, and regulatory compliance.
- Perform comprehensive product and process risk assessments utilizing established quality risk management methodologies (e.g., FMEA, risk matrices) and implement appropriate mitigation and monitoring strategies.
- Create, maintain, and continuously update Product Master Files (PMFs) and related technical documentation, ensuring all product, process, and transfer changes are accurately reflected and controlled.
- Support continuous improvement initiatives by applying Lean Manufacturing, Six Sigma, or equivalent quality improvement methodologies where applicable.
- Prepare technical reports, quality summaries, management presentations, and customer communications to support decision-making and regulatory compliance.
Requirements
- Bachelor's degree or higher in Quality Engineering, Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related technical discipline.
- Proficiency with Microsoft Office Suite and experience using Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) systems, Quality Management software, and other manufacturing information systems.
Benefits
- Equivalent technical education combined with significant relevant professional experience will also be considered.
- Comprehensive understanding of Quality Management Systems (QMS) for Medical Devices and applicable quality standards, including implementation and continuous improvement of quality processes.
Apply directly at Gerresheimer →Create a free account for alerts like thisView Gerresheimer immigration profile
This listing is sourced directly from Gerresheimer's careers page and normalized into a canonical job model.