Senior Quality Engineer
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Job Location:
Peachtree, GA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Department:
Job Summary
Were looking for a detail-oriented and driven Validation Engineer to lead the planning coordination and execution of validation and qualification activities for both production and support processes. This role is essential to maintaining our high standards in compliance documentation and risk management in line with global regulatory requirements.
Qualifications :
Independently plan and execute validation and qualification activities across projects
Analyze test results manage deviations and evaluate changes impacting validated states
Prepare and maintain comprehensive documentation in compliance with ISO and FDA standards
Support internal and supplier audits customer declarations and requalification efforts
Collaborate cross-functionally to support regulatory and quality compliance initiatives
Contribute to continuous improvement in validation processes documentation and best practices
Lead or support risk management activities during project execution
Additional Information :
Required Qualifications
Bachelors degree in Mechanical Engineering Industrial Engineering or a related technical field
Minimum of 5 years experience in quality assurance qualification and/or validation
Deep understanding of verification validation and regulatory standards
Technical Expertise
Solid knowledge of GMP ISO 13485 ISO 14971 ISO 15378 MDR and 21 CFR 820
Proficiency with digital systems including MES ERP Microsoft Office Minitab and quality management tools
Advanced knowledge of statistical and problem-solving methods (e.g. Kepner-Tregoe)
Skilled in project management principles and writing technical reports
Personal Competencies
Proactive reliable and flexible with a hands-on mindset
Strong interpersonal skills and emotional resilience
Excellent communication skills and ability to work well in cross-functional teams
Fluent in English (German is a plus)
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Quality Assurance
- Six Sigma
- Design Controls
- FDA Regulations
- ISO 9001
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
Gerresheimer is an innovative systems and solutions provider for pharmaceutical primary packaging, drug delivery systems, medical devices and associated service, and as such a strategic partner for the global pharma and biotech industry. www.gerresheimer.com
