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The Quality Engineer I supports Quality Assurance operations in a regulated manufacturing environment. This role partners closely with cross-functional teams to manage nonconformances, support investigations, and drive risk-based quality decisions while promoting a strong quality culture on the manufacturing floor.
Job Responsibility:
Represent Quality Assurance in cross-functional Daily Management meetings
Follow up on quality-related blocking issues and implement countermeasures
Manage and facilitate Material Review Board (MRB) activities
Ensure thorough, data-driven documentation of nonconformances
Support risk-based product disposition decisions
Assist with investigations to ensure they are well designed, executed, and documented
Manage corrections and corrective actions (CAPA)
Review quality data and perform trend analysis
Support Global Supply Chain and internal business partners as needed
Ensure compliance with GMP, ISO, and internal quality system requirements
Promote continuous improvement and quality-first mindset
Requirements:
Bachelor’s degree or equivalent in a scientific or related discipline
0–2 years of relevant experience or equivalent education/experience
Knowledge of GMP and ISO regulations in regulated manufacturing (preferred)
Basic understanding of risk management principles and medical device quality requirements
Exposure to Quality Engineering methodologies
Six Sigma Green Belt certification a plus
Familiarity with statistical methods, SPC, or experimental design preferred
Ability to work effectively in a fast-paced, cross-functional environment
Strong documentation, communication, and organizational skills
Nice to have:
Six Sigma Green Belt certification
Familiarity with statistical methods, SPC, or experimental design