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Pracovní nabídka

The Quality Management Specialist is responsible to support the continuous improvement, compliance, monitoring, and harmonization of an integrated medical device Global Quality Management System applicable to the Nobel Biocare Group (with focus on quality and operations related processes), and to support different Life Cycle Management activities to ensure compliant execution.

• Create, update, and maintain QA documentation in accordance with approved procedures and regulatory requirements (e.g., ISO 13485, FDA QSR).
• Perform document control activities, including review, approval coordination, issuance, revision, and archiving per QMS requirements.
• Ensure accuracy, completeness, and compliance of controlled documents following GDocP.
• Support training record management and timely completion of required QMS training.
• Coordinate and support Change Requests, ensuring timely processing, execution, and closure.
• Prepare, review, and verify change documentation for completeness, quality, and regulatory compliance prior to release.
• Maintain and control change-related documentation and technical data in SAP DMS in accordance with QMS and GDocP.
• Organize and chair Change Approval Board (CAB) meetings for product changes at the Zurich site, including agenda preparation and documentation.
• Act as a subject matter expert for Change Control, providing day-to-day guidance and training to stakeholders.
• Support continuous improvement initiatives related to Change Control and SAP DMS.
• Support critical and time-sensitive quality topics, including non-conformances, deviations, production issues, and field actions (e.g., recalls).
• Assist with investigations, root cause analysis, and documentation of CAPA activities.
• Support Health Hazard Evaluations and risk-based assessments under guidance from senior staff.
• Participate in internal and external audits by preparing documentation and supporting follow-up actions.
• Act as process owner or contributor for assigned quality processes under supervision.
• Support continuous improvement, digitalization, and automation initiatives across QMS processes.
• Participate in global and cross-functional projects to improve quality system effectiveness.
• Monitor assigned quality processes using defined metrics and report results to Quality Management.
• Collaborate with cross-functional teams to ensure quality requirements are integrated throughout the product lifecycle.
• Communicate quality requirements clearly and escalate quality or compliance risks as appropriate.

Job Requirements

• Experience from regulated industry
• Some experience in quality area and documentation
• Fluent English
• Ability to start immediately
• High level of accuracy and attention to detail in day-to-day work, with strong organizational skills.
• Ability and willingness to quickly learn and effectively use multiple software applications and digital tools in a regulated environment.
• Ability to manage multiple tasks, prioritize work, and meet deadlines in a structured environment.

What can you look forward to?

• WELL certified offices we’re the only office in CEE with Platinum certification in WELL - program that guarantees and monitors highest quality in physical office environment (used materials, quality of air/water, room temperature...) initiatives supporting mental wellbeing of employees (casual dress code, webinars, sport challenges)
• Ulekare.cz – medical support for you and your family (24/7 medical consultation, appointments, vaccinations)
• 25 days of vacation
• 4 paid sick days
• Meal vouchers
• Hybrid work model
• Contribution to wellness and leisure activities - Multisport and Edenred
• Retirement plan contribution and life insurance
• Language courses
• Employee Assistance Program (free consultations in mental health, legal and financial areas for you and your family members
• Company discounts
• Attractive work environment in Prague 8 – Libeň
• Free parking in the office