Senior Quality Engineer - Job Description
Responsibilities:
- Log and investigate customer complaints, assess whether submissions to regulatory agencies are required, and handle customer communications related to complaints.
- Assist with managing and submitting recalls, Field Safety Notices (FSNs), and adverse event reports.
- Prepare and present monthly quality trending reports.
- Coordinate and process nonconformance reports, including logging and investigating issues.
- Manage the rework process for products to meet quality standards as necessary.
- Log and manage supplier corrective actions (SCARs), ensuring appropriate follow-up.
- Coordinate and oversee the calibration of inspection and testing equipment.
- Conduct supplier evaluations and monitor supplier performance through both on-site (desk audits) and off-site (supplier site) assessments.
- Maintain and manage external standards indexes.
- Assist with external and internal quality audits, including those by customers and regulatory authorities.
- Log and manage Corrective Action/Preventive Action (CAPA) plans.
- Create product labels for manufacturing processes.
- Provide support and guidance for change orders, ensuring compliance with quality requirements.
- Assist with international requests for product registration information.
- Support regulatory functions as needed, including participating in internal and external audits.
- Collaborate with Engineering, Manufacturing, Procurement, and Inspection teams to ensure adherence to quality standards.
- Review and approve Quality System (QS) documents related to New Product Development (NPD), current products, and distributed products.
- Review and approve engineering protocols and reports as necessary.
- Monitor, review, and report on environmental conditions within the plant.
- Review, report, and archive Scrap Reports for analysis and record-keeping.
Location: Clearwater, FLWork Environment: OnsiteEmployment Type: Full-Time