Senior Quality Engineer
Company Description
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
Job Description
We’re 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
Bachelor's 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)
Average salary estimate
If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.
Senior Metal Bellows is hiring a Senior Quality Engineer to lead quality systems, audits, and continuous improvement for precision metal bellows used in aerospace and defense applications.
Intermountain Health seeks an experienced MLS Technical Specialist to lead QC, validations, instrument implementation, and regulatory compliance for laboratory services at Platte Valley Hospital.
Safran Passenger Innovations is hiring a Senior Software Engineer in Test Automation to validate and improve IFEC product quality through manual and foundational automation testing.
Silfab Solar seeks a Customer Quality Engineer to lead customer-focused quality investigations, RMA/RCCA processes, and continuous improvement initiatives at its Burlington manufacturing site.
GSK is hiring an experienced QA Technical and Validation Manager to lead validation strategy, tech transfer oversight, and GxP compliance for manufacturing and analytical operations at the Marietta site.
Experienced healthcare quality professional needed to lead evidence-based population health programs, ensure compliance with accreditation and CMS standards, and drive measurable improvements across assigned measures.
DroneSense is hiring a Senior QA Engineer to own manual and automated testing of our drone software platform, ensuring reliable releases that support first responders in the field.
Alphatec Spine is hiring a Mechanical Quality Engineer II to drive quality for mechanical implants and instruments through new product introductions and supplier qualifications.
Support Hovione's QC operations in East Windsor as an Associate Analyst performing routine GMP laboratory analyses, instrument upkeep, and data recording to ensure product and process quality.
Guidehouse is hiring a Jr–Mid Manual Tester (EHR) to validate Cerner modules, troubleshoot HL7 interfaces, manage ALM test cases, and support clinical and technical teams in a remote, healthcare-focused QA role.
Abbott’s Structural Heart team is hiring a Supplier Quality Engineer II to lead supplier audits, CAPA management, and supplier qualification activities at the Westfield, IN site.
Atomic Industries is hiring a hands-on Quality Manager to own injection molding quality, lead PPAP and root cause activities, and drive QMS implementation as the company scales.
Pfizer is hiring a Quality Risk Management Manager in Kalamazoo to lead QRM programs, maintain QRM tools and libraries, and provide guidance to site teams to ensure compliant, risk-based quality practices.
Gerresheimer is a German manufacturer of primary packaging products for pharma and healthcare industries. The company is headquartered in Düsseldorf, Germany.
7 jobs
🔮
Hi, I'm Risa! Your AI Career Copilot
you, just ask me below!
