Associate Production Quality Engineer
About The Position
The Associate Production Quality Engineer supports quality assurance activities within manufacturing operations and supplier quality management processes. Working under the guidance of the Senior Quality Assurance Engineer, this role helps ensure products are manufactured and released in compliance with applicable regulatory requirements, quality standards, and company procedures. The position contributes to production quality oversight, supplier performance monitoring, nonconformance investigations, and continuous improvement initiatives to support operational excellence and product quality. The role supports daily manufacturing quality activities, reviews production records and quality documentation, assists with process reviews and inspections, and helps investigate nonconforming materials and products. It also contributes to CAPA activities, supplier quality issue resolution, quality system documentation, audits, data analysis, and process improvement projects. Travel is 5%.
Requirements
- Bachelor’s degree in Engineering, Manufacturing Engineering, or a related technical discipline.
- 0 to 3 years of experience in Production Quality, Quality Engineering, Manufacturing Quality, or a related function.
- Basic knowledge of Quality Management Systems, 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.
Nice To Haves
- Experience in a regulated industry such as medical devices or a related field.
Responsibilities
- Support daily quality activities related to manufacturing operations and production processes.
- Review production records and quality documentation for completeness, accuracy, and compliance with established procedures.
- 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.
- Support investigations of deviations, nonconformances, and production quality events.
- Participate in root cause analysis using methods such as 5-Why, Fishbone Analysis, and Risk Assessments.
- Assist in developing, implementing, and monitoring Corrective and Preventive Actions (CAPAs).
- Verify completion and effectiveness of corrective actions within established timelines.
- Collaborate with the Supplier Quality Engineer to resolve supplier-related quality issues affecting manufacturing operations.
- Escalate supplier-related nonconformances to the Supplier Quality Engineer for investigation and resolution.
- Assist in reviewing supplier documentation, quality records, and corrective action responses.
- Collaborate with Supply Chain and Supplier Quality personnel to ensure timely resolution of supplier quality concerns.
- Maintain compliance with company quality system requirements and applicable regulatory standards.
- Assist in creating, revising, and maintaining quality procedures, work instructions, and records.
- Support internal, external, and customer audits, as well as regulatory inspections.
- Ensure quality documentation is completed accurately and maintained according to record retention requirements.
- Participate in continuous improvement projects focused on 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
