Sr Product Quality Engineer (f/m/d)
External
Eresearchtechnology · Estenfeld, BayernFull-timeUnknown1w ago
AgileComplianceDocumentationGCP
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Benefits
*Competitive compensationFlexible 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 DOINGEnsure 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 FORBachelor'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%).AnsprechpartnerNathalie FischerJetzt bewerben [https://clarioclinical.wd1.myworkdayjobs.com/en-US/clarioclinical_careers/details/Sr-Product-Quality-Engineer--f-m-d-_R17413]
Additional Information
SR PRODUCT QUALITY ENGINEER (F/M/D) 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.
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