Quality Planner

At Ottobock, we help people maintain or regain their freedom of movement. To support our continued growth and strengthen our quality organization in Bulgaria, we are looking for an experienced and motivated Quality Planner.

In this role, you will be an integral member of cross-functional product development teams. You will ensure that quality is systematically planned and embedded throughout the entire product lifecycle – from development and industrialization to production launch and ramp-up phase.

Your Responsibilities:

• Act as the responsible quality-planning representative for assigned product development and change projects.
• Plan, coordinate and maintain the quality-planning activities required to achieve the intended product and manufacturing-process quality.
• Plan, facilitate and maintain Design and Process FMEAs.
• Monitor the timely implementation and effectiveness of actions resulting from FMEAs and other risk assessments, including technical measures such as design changes required to achieve predefined quality requirements.
• Develop and maintain project-specific test concepts and production control plans.
• Define appropriate quality-assurance activities across the relevant manufacturing processes.
• Plan and coordinate inital sample inspection (ISI), pilot-series and initial-series quality activities, including the required documentation and initial sample inspection reports (ISIR) .
• Conduct or coordinate manufacturing-process reviews and support production-readiness assessments.
• Identify and evaluate potential quality, safety and First Pass Yield risks.
• Analyse available field and complaint data for predecessor or technically related products.
• Coordinate quality-planning schedules with project milestones, industrialization activities and planned product launches.
• Monitor quality-planning maturity and provide clear and transparent quality-status reporting.
• Escalate potential quality and safety risks at an early stage.
• Support product and process changes by updating the relevant quality-planning documentation and controls.
• Support internal and external audits related to Advanced Quality Planning.
• Contribute to the continuous improvement and cross-site harmonization of quality-planning processes.
• Collaborate closely with R&D, Production Engineering, Quality Assurance, Regulatory Affairs, Quality Management, Clinical Research, Project Management, Purchasing and other relevant functions.

Your Profile:

• Bachelor’s or Master’s degree in engineering, quality management, medical technology, manufacturing engineering or another comparable technical field.
• Professional experience in quality planning, quality assurance, product development or manufacturing, preferably within a regulated industry.
• Practical knowledge of quality-planning methods, particularly Design and Process FMEA, intial sample inspection and approval activities, test concepts and production control plans.
• Good understanding of risk-based quality planning and the interaction between product development, industrialization and operations.
• Knowledge of quality-management requirements such as EN ISO 13485, EU MDR and the FDA QM System Regulation (QMSR, 21 CFR Part 820) would be an advantage.
• Experience with complaint data, root-cause analysis, quality KPIs and effectiveness monitoring.
• Experience working in cross-functional and international project teams.
• Very good written and spoken English and Bulgarian, German language skills would be an advantage.
• Confident user of Microsoft 365; experience with quality, PLM, ERP or project-management systems would be an advantage.
• Willingness to travel and collaborate with colleagues across different Ottobock locations when required.

What Defines You:

• You work in a structured, independent and systematic way.
• You have a strong awareness of quality and risk.
• You are proactive, accountable and focused on finding solutions.
• You communicate clearly and constructively across functions and locations.
• You are confident in facilitating workshops and technical discussions.
• You can prioritize and coordinate several project activities simultaneously.
• You combine a collaborative mindset with sound judgement and the confidence to address risks when necessary.
• You are customer-, service- and result-oriented.

What You Can Expect:

• A meaningful role in a company whose products help people maintain or regain their freedom of movement.
• The opportunity to contribute to innovative medical-technology products throughout their development and industrialization.
• Collaboration with international, cross-functional teams and experts across the Ottobock organization.
• A responsible position with the opportunity to influence product and process quality from an early stage.
• A professional environment that encourages continuous improvement, knowledge sharing and personal development.

If you would like to contribute your expertise to the quality and safety of products that make a real difference in people’s lives, we would be pleased to receive your application.

Join Ottobock and help us improve freedom of movement.

Disclaimer: Only short-listed candidates will be contacted. All documents will be treated with the strictest confidentiality.