Associate.Quality Assurance
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Summary
On-site Associate Quality Assurance role at Invacare's Elyria, OH medical equipment plant. Day to day: investigating nonconformances and customer complaints, managing concessions, inspecting returned products (RMAs), supporting root-cause/corrective actions, and keeping quality records compliant with the QMS and regulatory requirements.
Essential Functions:
- Assist Quality personnel with investigations of nonconformances, customer complaints, and production-related quality issues.
- Coordinate and manage the concession process from initiation through final disposition, ensuring all required documentation and approvals are completed.
- Review concession requests for completeness, supporting documentation, and required approvals.
- Track concession approvals, expiration dates, and required follow-up actions, and escalate overdue or expired concessions as appropriate.
- Coordinate and perform inspections of returned products associated with RMAs.
- Inspect returned products to determine the nature and extent of reported issues and document inspection findings.
- Evaluate returned products against applicable specifications, drawings, work instructions, and acceptance criteria.
- Ensure RMA inspection results are accurately documented and linked to the applicable complaint, NCR, CAPA, or other quality record, when required.
- Assist with root-cause analysis, investigation, and corrective action activities.
- Maintain accurate and timely records related to concessions, RMAs, inspections, nonconformances, and product dispositions.
- Assist with the collection, organization, and presentation of quality data required to support internal audits, customer audits, and regulatory assessments.
- Provide support during customer complaint investigations, including gathering product, process, inspection, and historical quality information as needed.
- Utilize the Information Center and applicable company systems to retrieve product, process, quality, and historical information.
- Ensure strict compliance with established Quality Management System procedures, work instructions, and applicable quality and regulatory requirements.
- Complies with Good Documentation Practices
- Adheres to all safety policies and contributes to the achievement of safety goals & objectives
- Provides ideas and actively participates in the implementation of written suggestions for continuous improvement
- Effectively utilizes time, energy and resources to meet delivery goals
- Maintains housekeeping standards in accordance with 5 S principles
- Complete all required training applicable to assigned position
- Exhibit positivity, flexibility, creativity, and a willingness to take on new responsibilities as requested or required