Work Flexibility: Onsite

What you will do

In this role, you will support the implementation and maintenance of the Quality Management System as part of a product transfer program. You will work closely with manufacturing and engineering teams to ensure processes, validations, and inspection systems meet regulatory and customer requirements.

Main responsabilities:

• Support quality activities associated with product transfer programs, ensuring compliance with regulatory and internal quality standards.

• Develop and implement inspection plans, sampling plans, and quality inspection documentation for components and finished products.

• Support process and product validation activities, including IQ, OQ, PQ, and Measurement System Analysis (MSA).

• Monitor and analyze quality performance indicators and support corrective and preventive actions related to project objectives.

• Conduct process time studies and quality assessments to support process optimization and production readiness.

• Lead or support investigations related to nonconformances, CAPA, and quality events.

• Participate in internal and external audits and support compliance with ISO 13485 and regulatory requirements.

• Provide hands-on quality support on the production floor, collaborating closely with manufacturing, engineering, and operators.

What you need

Required

• Bachelor’s degree in Engineering.

• Minimum 2 years of experience in quality engineering, preferably in the medical device industry.

• Experience supporting product transfer or new product introduction projects.

• Knowledge of validation activities (IQ, OQ, PQ) and quality investigations.

• Knowledge of ISO 13485 and applicable medical device regulations.

• Experience with inspection plans and quality documentation.

• Fluent conversational English.

Preferred

• Six Sigma Green Belt certification or equivalent training.

• Experience using statistical tools such as Minitab.

Travel Percentage: 30%