Senior Product Quality Engineer (Medtech)

TL;DR

Senior Product Quality Engineer (Medtech): Establishing and maintaining compliance with the Quality Management System (QMS) for medical and non-medical devices with an accent on design controls and regulatory standards. Focus on providing quality guidance throughout the product lifecycle, supporting validation activities, and ensuring alignment with ISO, FDA, and MDR regulations.

Location: Estenfeld, Germany

Company

hirify.global, part of Thermo Fisher Scientific, is a company dedicated to transforming lives by unlocking better evidence through clinical science and innovative technology.

What you will do

• Ensure implementation of control processes like PLC, DLC, and SDLC across global projects.
• Review technical documentation to ensure alignment with global standards and regulations.
• Provide regulatory guidance to cross-functional teams throughout the product lifecycle.
• Support validation activities to confirm products meet intended use requirements.
• Resolve quality issues and support continuous improvement initiatives.
• Participate in internal and external audit activities to ensure QMS compliance.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or an equivalent discipline.
• Minimum 5 years of experience with Design Controls or QMS in a regulated environment.
• Minimum 5 years of experience in GMP and/or GCP regulated environments.
• Minimum 2 years of hands-on experience with ISO and/or GCP standards.
• Experience supporting Agile development in a regulated environment.
• Professional working proficiency in English.
• Willingness to travel internationally (up to 25%).

Nice to have

• Auditor experience in a GCP/GMP environment.

Culture & Benefits

• Competitive compensation package.
• Flexible working hours and time accounts to support work-life balance.
• Access to internal and external training and certification programs.
• Comprehensive benefits focusing on security, flexibility, and well-being.
• Participation in engaging employee programs.