Join Clario, part of Thermo Fisher Scientific, 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, part of Thermo Fisher Scientific, 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.
Skills Required
- Bachelor's degree in Engineering, Life Sciences, or equivalent
- At least 5 years of experience with Design Controls or Quality Management Systems
- At least 5 years of experience in GMP and/or GCP regulated environments
- At least 2 years of hands-on experience working with ISO and/or GCP standards
- Experience supporting Agile development in a regulated environment
Clario Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Clario and has not been reviewed or approved by Clario.
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Leave & Time Off Breadth — Time off is described as generous, including flexible PTO for some roles and up to 26–31 PTO days for eligible staff. The calendar includes 15 paid company holidays and a Winter Break.
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Healthcare Strength — Healthcare offerings include multiple medical plan options via Highmark with coordinated care navigation, plus dental and vision through established carriers. Employer HSA contributions and mental-health support broaden the package.
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Inclusive Benefits Coverage — Coverage highlights include domestic-partner eligibility, transgender-inclusive care, and HIV prevention/treatment. These inclusive elements are presented alongside broader inclusion commitments.
Clario Insights
What We Do
-- Clario has been named a Top Workplace by Energage for the 2022 Top Workplaces USA national awards. -- Clario generates the richest clinical evidence by fusing our deep scientific expertise and global scale into the broadest endpoint technology platform. By doing this, we empower our partners to transform lives. With almost 50 years of experience, 19,000 clinical trials, and 870 regulatory approvals, Clario has mastered the ability to generate rich evidence across a Trial Anywhere™ portfolio: decentralized (DCT), hybrid and site-based clinical trials. With 30 facilities in nine countries across North America, Europe, and Asia Pacific, Clario delivers the power of certainty. Partners ————— Clario brings the best of ERT and Bioclinica together to work alongside our partners to solve some of their biggest questions on topics such as: - eCOA vs. paper - Decentralized Clinical Trial (DCT) - Rescue a clinical trial - Broad endpoint technology: cardiac safety, imaging, respiratory And many more. People ———— We are so honoured to be named a 2022 Top Workplace by Energage. One of our leading values at Clario is People First Always. We help individuals build meaningful careers at Clario as they serve to help transform patients lives. Join us on this journey and check out our careers page: https://clario.com/careers/
