Quality control engineer állások, munkák Németországban

• Develop and maintain automated tests: automate when it makes sense, think about ROI, don't overengineer solutions.
• Own the testing and quality processes of the team
• Improve the development process
• Lead the QAs of the hardware development unit
• Maintain and improve the testing infrastructure

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

Management of regional and local Quality & HSE Team and activities as well as implementation of group-wide initiatives and projects, including qualification and personnel development...

_Ensure compliance with automotive standards such as IATF 16949, VDA, and OEM-specific requirements_ _Support the process team to create and maintain process documentation including SOPs, work instructions, PFMEA, control plans, and process flow diagrams_ _Support new product introductions (NPI),...

• Guiding and supporting your team by overcoming roadblocks and exceeding expectations
• Ensuring appropriate staffing for all active Simultaneous Development Teams (SDTs) in collaboration with Program Management and Quality leadership

Following up on production-related nonconformities, supporting root cause analyses, defining and monitoring corrective actions, and preparing evaluations and statistics of nonconformities...

Plan, Conduct, and Follow Up on Pharmacovigilance Audits including oversight and training of external service providers and consultants (for audits), ensuring adherence to company standards and regulatory requirements...

• Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

• Manage and monitor supplier quality performance to ensure compliance with company standards
• Conduct supplier audits and assessments to evaluate manufacturing and quality systems
• Handle supplier quality issues and drive root cause analysis and corrective actions

• Ensures the highest standards of quality and regulatory compliance across the organization, fostering a culture of excellence
• Develops and implements quality management systems, driving continuous improvement initiatives

• Ensure each site supports effective CAPA implementation and continuous improvement.
• Lead the CAPA Review Board to drive alignment with quality goals and expectations across the organization.

You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements...

Ensure compliance with and further development of quality standards and processes across all brands of the Huber Group (Huber, Hanro, Skiny, Hom, Gossard)...

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

Build and Empower: Take full ownership of the Quality Assurance team. You will be responsible for structuring the department, hiring specialists, and fostering a culture of precision and excellence from the ground up....