Quality Engineer (On-site)

General Responsibilities

• Supports Quality Management for executing the quality engineering activities related to the design and manufacture of the products in compliance with the Quality Management System requirements and the regulations of the countries where the franchise distributes and sells products.
• Supports Nonconforming product handling by collecting and critically analyzing data and taking disposition decisions on nonconforming products identified in production.
• Leads proper investigation to identify the causes of components / product failures (nonconforming products from production and complaints).
• Generates the evaluation of the risk posed by the observed NC on products already distributed (Health Hazard Evaluation) to help management determine if Stop Shipment and/or Field Action is initiated.
• Led CAPA projects and trend data to identify opportunities for future CAPA.
• Whenever applicable, supports external manufacturers of semi-finished and finished products in the management of any detected nonconformities.
• Notifies suppliers of any non-conformance related to purchased material and evaluates corrective actions consistency versus internal controls.
• Supports Design Control & Production and Process control by establishing product quality control inspections/plans, reviewing process validation planning, protocols and reports, performing preliminary review of the change impact assessment to confirm that quality requirements are met, establishing and maintaining Risk Management files, collaborating in the investigations into the cause of V&V failures, and identifying opportunities for quality improvements in the production area and leading improvement plans.
• Analyzes Analysis of Complaint data and Returned Products by daily management of the assigned complaint handling activities, providing daily support, as needed for: customer-related processes involving use of the device, complaint evaluations and investigations, and supporting timely analysis to meet Customer Quality complaint and MDR reporting quality metrics. Leads effective meetings, conducts presentations, establishes quality records, develops effective relationships with internal personnel and external stakeholders to assist customers and drive the resolution of customer complaints.

Skills And Experience

• Minimum related work experience of 1-3 years in Class II/III medical device manufacturing or related regulatory industry.
• Knowledge of regulatory requirements (e.g., FDA, ISO 13485) as required for the position.
• Experience with MDSAP and Medical Device Requirements is a plus.
• Proficiency with quality tools such as flowcharts, statistical data analysis, mathematical reasoning.
• Ability to analyze and problem-solve with CAPA experience.
• Ability to work within a changing environment.
• Ability to work with a wide variety of personnel on all levels and utilize constructive confrontation.
• ASQ Certified Quality Engineer or other ASQ Certifications is a plus.
• Excellent communication (written and verbal) and presentation skills.
• Able to communicate across functional lines.

Education

• Bachelor’s Degree in Technical and Scientific disciplines (Engineering, Physics, Chemistry, and Biology).