Senior PD Quality Engineer — Medical Device Quality Leader

Fresenius Medical Care; Reynosa; Vor Ort; MXN 420.000 - 640.000; Vollzeit

Zusammenfassung

Fresenius Medical Care is seeking a Senior PD Quality Engineer to ensure the quality and reliability of PD disposables and related products at the Reynosa site. You will use advanced statistical methods, validation approaches, and problem‑solving tools to drive continuous improvement and regulatory compliance.

The role requires collaboration with cross‑functional teams, handling CAPAs, and supporting product transfers and change controls across the PD manufacturing area.

Qualifikationen

• Bachelor’s degree in Electronic, Mechatronic, or related engineering field.
• Minimum 2 years in Quality Engineering or Manufacturing Engineering; medical device experience preferred.
• Experience with problem-solving and root cause analysis; Six Sigma knowledge desired.
• Experience with process validation and validation of physical test methods.
• Experience applying statistical tools to product and process analysis.

Aufgaben

• Develop and implement test methods for medical devices and equipment.
• Support the evaluation and investigation of customer complaints and the Entwicklung of CAPA for the PD area.
• Monitor internal nonconformances and support corrective and preventive actions in cross-functional teams.
• Perform risk assessments to support the PD Manufacturing area in closing nonconformances.
• Conduct regular walkthroughs in the PD manufacturing area to identify improvement opportunities.
• Support product and process validations, including preparation of validation protocols.
• Apply statistical techniques to evaluate and analyze products and processes for continuous improvement.
• Support regulatory compliance with FDA, ISO, and MDD requirements.
• Review drawings, fixtures, and Instrument Specification Sheets (ISS).
• Support design transfer activities and new methods development.

Kenntnisse

Root Cause Analysis

Six Sigma

Statistical tools

Process validation

Minitab

Problem solving

Communication

Bilingual English/Spanish

Ausbildung

Electronic/Mechatronic Eng

Tools

MS Office

Minitab

Jobbeschreibung

Fresenius Medical Care is seeking a Senior PD Quality Engineer to ensure the quality and reliability of PD disposables and related products at the Reynosa site. You will use advanced statistical methods, validation approaches, and problem‑solving tools to drive continuous improvement and regulatory compliance.

The role requires collaboration with cross‑functional teams, handling CAPAs, and supporting product transfers and change controls across the PD manufacturing area.