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.