mployment Type: No C2C, W2 only. No H1B Visa.
The Quality Engineer will support compliance, quality improvement initiatives, complaint handling, corrective actions, and validation activities within the manufacturing environment. The individual will collaborate with cross-functional teams to maintain quality standards, drive continuous improvement, and ensure compliance with FDA QSR and ISO 13485 requirements.
Duties and Responsibilities
Customer-Facing Metrics (CFM)
Monitor and improve performance to CFMs.
Support processes that enhance compliance with customer delivery timelines by investigating late deliveries and recommending improvements.
Assist in resolving customer complaints by conducting thorough investigations and ensuring timely responses.
Complaint and Corrective Action Management
Investigate quality-related complaints, perform root cause analysis, and recommend corrective actions.
Ensure proper documentation of corrective actions and follow-up to confirm effective implementation.
Support the preparation of CAPAs, Alerts, and other quality-related documents.
Scrap Reduction and Non-Value-Add Activities
Analyze scrap and non-value-add activities to identify trends and recommend improvement solutions.
Engage with teams to implement data-driven solutions for scrap reduction.
Compliance/Certification
Maintain the site’s Quality Management System in alignment with FDA QSR and ISO 13485 standards.
Support internal audit activities and ensure follow-up actions are completed.
Assist with management reviews to ensure effective systems review and improvement opportunities.
Validation Activities
Participate in product and process validation activities, including protocol development, execution, and reporting for IQ, OQ, and PQ.
Provide support for technical reviews, feasibility discussions, and Failure Modes and Effects Analysis (FMEA).
Continuous Improvement
Use data analytics to identify areas for process improvement.
Create charts, graphs, and presentations to support quality meetings and decision-making processes.
Assist in developing solutions to improve on-time delivery and overall product quality.
Cross-Functional Collaboration
Work closely with manufacturing, engineering, and other teams to ensure alignment with quality objectives.
Provide input on product and process improvements, leveraging statistical tools and quality principles.
Other Responsibilities
Support new product introductions and changes by participating in design reviews and process improvements.
Contribute to quality-focused initiatives as assigned by the Quality Manager.
Qualifications
Bachelor’s Degree in Engineering, Science, or related field required.
2-3 years of experience in quality engineering, preferably in a medical device or regulated manufacturing environment.
Knowledge of ISO 13485 and 21 CFR 820 quality system requirements.
Proficiency in MS Office tools (Word, Excel, Project) and statistical software like Minitab®.
Strong analytical skills and experience with root cause analysis and corrective actions.
Ability to interpret technical instructions, analyze data, and draw actionable conclusions.
Excellent communication and collaboration skills, with an ability to work across functions effectively.
Experience with Lean Manufacturing principles and continuous improvement initiatives.
Job Type: Contract
Pay: $40.00 per hour
Expected hours: 40 per week
Schedule:
- 8 hour shift
- Monday to Friday
Experience:
- ISO 9001: 4 years (Required)
- CAPA: 4 years (Required)
- ISO 13485: 4 years (Required)
Work Location: In person