Operations QA Engineer

Roles & Responsibilities

·        Support the Operations department activities (warehouse, supply chain, production, NPI) with all quality controls and demands.

·        Initiate and implement MRB process for non-conforming materials: initiation, segregation, investigation including corrective actions until final disposition.

·        Manage the measuring and production equipment to ensure timely calibration and maintenance in accordance with applicable standards

·        Review quality documentation for design changes. DMR maintenance.

·        Lead supplier control activities: evaluation, selection and monitoring of the company’s suppliers and service providers. Conduct periodic supplier audits and inspections. Initiate supplier corrective action requests (SCARs) and follow up on their resolution. Maintain and update the approved supplier list (ASL).

·        Facilitate the complaint handling process: receiving, evaluation, leading the investigations and root cause analysis of complaints, maintenance of the complaint records in the complaint handling database, analysis of complaint data and trends

·        Support R&D and Operations in failure investigation

·        Support CAPA activities throughout different CAPA stages from the investigation to closure.

·        Analyze quality data to identify trends and create statistics related to QA oversight in operations.

·        Support continuous improvement initiatives and projects to enhance product quality and operational efficiency.

·        Participate in internal and external audits, inspections, and certifications, and ensure readiness for regulatory submissions and approvals.

Skills and Experience

·        A bachelor’s degree in engineering, quality, or a related field.

·        At least 5 years of experience in quality engineering and quality assurance in the medical device industry.

·        Knowledge of quality standards and regulations for medical devices, such as ISO 13485, FDA QSR, MDR, etc.

·        Experience in quality tools and techniques, such as FMEA, SPC, CAPA, root cause analysis, etc.

·        Experience in quality testing and validation methods, such as IQ/OQ/PQ – strong advantage

·        Strong analytical, problem-solving, and communication skills.

·        Proficiency in Microsoft Office and quality management software.

·        High proficiency in English

·        Knowledge in Priority ERP – strong advantage