Ensure that global QM projects meet quality, reliability, and regulatory requirements. As the international Quality Project Manager, this role coordinates projects from initial planning (concept, NPI) through to completion (handover to mass production) while aligning the relevant project resources across functions. The role is focused on a major strategic project involving the ramp-up of a new production line of critical importance to the company.
Responsibility
Main Task
- Project management and compliance
- Managing the project across business functions to ensure all requirements from a Quality Management perspective (strategic, legal, regulatory, and ZEISS policy) are met.
- Ongoing monitoring of the project to identify gaps against QM and reliability requirements. Defining and implementing countermeasures to fulfil quality requirements.
- Providing support for all major quality, reliability, and regulatory activities and initiatives, including quality system requirements, new product/process introductions, continuous improvement projects, product/process audits, reliability requirements and analysis, and regulatory product requirements validation.
- Managing project execution to ensure the schedule is met with no quality blockers. Overseeing and actively engaging in all quality and regulatory issues at an international level (FDA CFR 820, MDR, etc., but not limited to these).
- Presenting and discussing project, process, and product quality performance results and analysis with internal and external customers.
- Conducting gap analyses to monitor project status in terms of timing, budget, and performance. Defining and implementing corrective actions as needed.
- Implementation of QM Systems
- Requirements definition for the implementation of IT systems for Quality Management.
- Responsible for driving key APQP deliverables such as Product Control Plan, DFMEA, PFMEA.
- Responsible to review and approve qualification and validation protocols to ensure proper process implementation and correct measurements across the manufacturing line.
- Responsible for quality and quality-related project documentation, including knowledge transfer via training and handover to line managers, ensuring sustainable documentation and version control.
- Key point of contact for quality, regulatory, and reliability discussions with customers, including preparing, leading, and following up on online and onsite customer meetings.
- Ensuring proper communication with customers across the project structure.
- Escalating issues to the appropriate level as required.
- Actively leading initiatives to improve production efficiency and key performance indicators. Building and maintaining strong connections with all project stakeholders in support of the joint project goal.
Position Authorization
Review and approve TQ/TV/OR; Approve project PSGP/APQP.
Team performance appraisal. Team HC planning and salary/bonus recommendation.
Key Performance Indicator
Planning and overseeing product qualification from project initiation through to mass production.
Quality planning across product and process design phases.
Project quality deliverables and KPIs
Ensuring products are delivered to production smoothly.
Qualification
ducation Background
Education
Bachelor /Master-degree
Major
Engineering
Work Experience
Minimum 3 years of work experience as a DQE or QE
Knowledge And Skill
Project Management
Quality methodologies: Quality Planning (DFM, APQP, D/PFMEA, Control Plan), problem-solving techniques, and statistical tools
Knowledge of ISO 13485 and Six Sigma.
Fluent in English (listening, speaking, reading, and writing).
Behavioral Traits
Strong organizational and communication skills; team player with the ability to work effectively under pressure.
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