Participate in manufacturing process reviews, product inspections, and production readiness activities.
Assist with the evaluation, investigation, and disposition of nonconforming materials and products.
Monitor quality-related production metrics and support implementation of corrective actions when required.
Collaborate with Production, Engineering, and Operations teams to address quality issues and improve manufacturing performance.
Nonconformance and CAPA Activities
Support investigations of deviations, nonconformances, and production quality events.
Participate in root cause analysis using quality problem-solving methodologies such as 5-Why, Fishbone Analysis, and Risk Assessments.
Assist in the development, implementation, and monitoring of Corrective and Preventive Actions (CAPAs).
Verify completion and effectiveness of corrective actions within established timelines.
Supplier Quality Support
Collaborate wiith Supplier Quality Engineer to support resolution of supplier-related quality issues impacting manufacturing operations.
Escalate supplier-related nonconformances to Supplier Quality Engineer for investigation and resolution.
Assist in the review of supplier documentation, quality records, and corrective action responses.
Collaborate with Supply Chain and Supplier Quality personnel to ensure timely resolution of supplier quality concerns
Quality Systems and Compliance
Maintain compliance with company quality system requirements and applicable regulatory standards.
Assist in the creation, revision, and maintenance of quality procedures, work instructions, and records.
Support internal audits, external audits, customer audits, and regulatory inspections.
Ensure quality documentation is completed accurately and maintained according to record retention requirements.
Continuous Improvement
Participate in continuous improvement projects focused on enhancing product quality, process efficiency, and compliance.
Analyze quality data and prepare routine reports and trending analyses.
Support implementation of risk management and process improvement initiatives.
Contribute to a culture of quality, compliance, and operational excellence.
Qualifications
Bachelor’ Degree in Engineering, Manufacturing Enginering, or related technical discipline
0 to 3 years of experience in Productio Quality, Quality Engineering, Manufacturing Quality or related function
Experience in regulated industry such as Medical device or other related field, preferred
Basic knowledge of Quality Management Systems (QMS), including ISO 13485, ISO 9001, FDA 21 CFR Part 820, or equivalent regulations.
Understanding of manufacturing processes and quality engineering principles.
Familiarity with nonconformance management, CAPA processes, and root cause analysis techniques.
Knowledge of Good Documentation Practices (GDP).
Proficiency in Microsoft Office applications.
Strong analytical, organizational, and communication skills.
Ability to work effectively in a cross-functional team environment.
Travel: 5%
Compensation Range: $85,000–$110,000
