Not specified (considering industry norms, likely hybrid or onsite)
Fda and international regulatory requirements knowledge
Iso 13485 and mdsap compliance expertise
Root cause analysis and capa management skills
Medtronic Diabetes is seeking a Quality Engineer to support their Quality Management System (QMS) and ensure compliance with regulatory requirements in the medical device industry. The role emphasizes the importance of collaboration, problem-solving, and effective communication in a mission-driven environment focused on healthcare innovation
Job Summary
This role involves providing quality system support to maintain compliance with FDA and international regulatory requirements for medical devices.
The position requires owning nonconform product investigations, performing root cause analysis, and driving corrective and preventive actions.
Medtronic offers a competitive salary, flexible benefits package, and opportunities for career growth through training and mentorship.
Matching Summary
Match Score: 85
Medtronic Diabetes is seeking a Quality Engineer to support their Quality Management System (QMS) and ensure compliance with regulatory requirements in the medical device industry. The role emphasizes the importance of collaboration, problem-solving, and effective communication in a mission-driven environment focused on healthcare innovation.
Salary
Base: 55,200.00 EUR - 82,800.00 EUR; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Competitive Salary and flexible Benefits Package
Skills & Requirements
Must-have
FDA and international regulatory requirements knowledge
ISO 13485 and MDSAP compliance expertise
Root cause analysis and CAPA management skills
Internal and external audit coordination experience
Medical device manufacturing process understanding
Nice-to-have
Proactive support for QMS process setup
Strong written and oral communication skills
Ability to manage multiple critical projects
Experience with EU OU Surgical entities
Data analysis and trend identification skills
Key Requirements
Bachelor's degree with 4 years relevant experience or advanced degree with 2 years
Demonstrated knowledge of FDA, GMP, QSR, ISO 13485, and MDSAP
2+ years experience in Medical Device Manufacturing setting preferred