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Responsible for reviewing and assessing Quality Notifications, Complaints, Deviations/Waivers, and other cGMP activities for assigned product lines in the instrument plant. Ensures compliance with internal Quality Policies, FDA, and GMP guidelines, conducts investigations, and provides technical input on quality-related issues.
Job Responsibility:
Oversee quality operations, ensuring adherence to documentation, procedures, and regulatory requirements
Conduct complaint investigations and assist in resolving manufacturing issues
Provide quality oversight for key suppliers, ensuring compliance with BD, FDA, and industry standards
Support supplier qualification, approvals, and lifecycle design control documentation
Facilitate supplier collaboration and establish initiatives to improve Supplier Quality Management Systems
Support field corrective actions as needed
Drive process improvements and risk management in supplier quality
Requirements:
Minimum 3 years in Quality/Supplier Quality within a manufacturing environment regulated by FDA/ISO standards
Strong understanding of QSR, GMPs, Design Control, and Product Risk Management
Experience managing contract manufacturers and various commodities (e.g., PCBAs, electronics, sheet metal, optics/lasers, cabling, chemistry, biological products)
Proficient in process development, optimization, and troubleshooting at both product and process levels
Experience with supplier capability assessments, auditing, and data-driven decision-making
Bachelor’s or Master’s degree in Engineering, Biological Sciences, Chemistry, or related field
Nice to have:
Professional certification (CQA, CQE, Six Sigma, etc.) is a plus