Sr Product Quality Engineer; f​/m​/d

Position: Sr Product Quality Engineer (f/m/d)
Location: Germany

Sr Product Quality Engineer (f/m/d) page is loaded## Sr Product Quality Engineer (f/m/d) locations:
Estenfeld, Germany:
Leuven, Belgium time type:
Full time posted on:
Posted Todayjob requisition :
R17413

Join Clario as Senior Product Quality Engineer (f/m/d) and work across Clario business lines to establish, maintain, and continuously improve compliance with Clario’s Quality Management System (QMS). You will provide quality and regulatory expertise throughout the product lifecycle, ensuring medical and non‐medical devices and solutions meet applicable global regulations and standards.
** What we offer
*** Competitive compensation
* Flexible working hours and working time accounts to support the work-life balance.
* Support your professional development through internal and external training and certification programs.
* Attractive benefits (security, flexibility, support and well-being).
* Engaging employee programs.
** What You’ll Be Doing
*** Ensure compliance with and implementation of Clario control processes (e.g., PLC, DLC, SDLC) across assigned global projects.
* Review development and technical documentation during global design projects, ensuring alignment with applicable standards and regulations.
* Provide quality and regulatory guidance to cross‐functional teams throughout the full product lifecycle.
* Ensure medical and non‐medical devices and solutions comply with applicable regulations and standards (e.g., ISO, FDA, MDR).
* Contribute to product reviews and design control activities.
* Support validation activities to confirm products meet intended use and indications for use requirements.
* Partner with internal departments to resolve quality issues and support continuous improvement initiatives.
* Support the Quality Management designee and participate in quality surveillance activities.
* Support the revision and maintenance of procedures, policies, and work instructions to ensure compliance with local and international regulations.
* Support internal and external audit activities, including project‐specific audits, to ensure compliance with Clario’s QMS.
* Serve as a member of the Designated Complaint Unit (DCU) and fulfill responsibilities as outlined in the associated appointment letter.
* Report project status, risks, deviations, and quality concerns to management, including recommended corrective actions.
** What We Look For
*** Bachelor’s degree in Engineering (technical or electrical), Life Sciences, or an equivalent discipline.
* At least 5 years of experience working with Design Controls (e.g., Computer System Validation) or Quality Management Systems in a regulated environment.
* At least 5 years of experience in GMP and/or GCP regulated environments.
* Experience supporting Agile development in a regulated environment.
* Minimum 2 years of hands‐on experience working with ISO and/or GCP standards.
* Auditor experience in a GCP/GMP environment is preferred.
* Strong troubleshooting, communication, and stakeholder‐management skills.
* Professional working proficiency in English.
* Willingness to travel internationally (up to 25%).At Clario, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.

Clario is a leading provider of endpoint data solutions to the clinical trials industry, generating high-quality clinical evidence for life sciences companies. We offer comprehensive evidence generation solutions that combine medical imaging, eCOA, precision motion, cardiac solutions and respiratory endpoints.

For more than 50 years, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported over 30,000 clinical trials in more than 100 countries. Our global team of science, technology, and operational experts have supported over 70% of all FDA drug approvals since 2015.
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