Engineer II, Quality

About the role

Join the Global Operations & Quality team to ensure medical devices for cardiovascular patients are delivered safely and compliantly. You will partner with manufacturing, operations and sales to solve complex quality challenges while deepening your expertise in the medical‑device industry.

Key responsibilities

• Investigate moderately complex manufacturing product quality and compliance issues, including PRAs, complaints, NCRs, CAPAs, ECRs and audit observations.
• Oversee product release, assess and disposition on‑hold items (MRB) and manage material quality control.
• Review and approve equipment validations, asset management actions and drive continuous improvement using Six Sigma, TOPP and LEAN methods.
• Collaborate with engineering teams on technology transfers, risk‑management files and pFMEA updates.
• Develop training and work‑instruction documentation for production and support process validation activities.

Required profile

• Bachelor’s degree in Engineering or a scientific field (or Master’s with relevant internship/project experience).
• At least 2 years of experience in quality engineering, manufacturing, or a related industrial environment.
• Demonstrated ability to work with cross‑functional teams and manage multiple priorities in a fast‑paced setting.

Required skills

• Proficiency with MS Office Suite.
• CAD software experience (preferred).
• Knowledge of statistical techniques and Six Sigma/LEAN methodologies.
• Experience with lab or industrial equipment and equipment validation.
• Familiarity with quality systems, NCR/CAPA processes, and risk‑management tools such as pFMEA.