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As Operations Quality Director, you will own and lead all quality aspects across operationsfrom NPI through ramp-up to mass productionensuring flawless execution, supplier performance, and metrology excellence.

Key Responsibilities:

Overall Quality Leadership

Lead all quality-related aspects within the Operations division, including NPI, ramp-up, mass production, and customer delivery.
Manage and mentor the operations quality team, fostering a culture of continuous improvement and accountability.
Ensure compliance with IATF 16949, VDA 6.3, AIAG standards, and all customer-specific requirements.
Drive implementation of automotive quality methodologies (APQP, PPAP, SPC, FMEA, Control Plans) throughout manufacturing and supply chain processes.
Act as the quality interface between R&D, operations, and suppliers during new product introductions and series production phases.
Core Focus Areas:

Supplier Quality Management

Define and execute the supplier quality strategy for new and existing suppliers.
Lead supplier selection, development, and qualification activities, including Process Audits, APQP, PPAP, etc.
Oversee incoming quality control, first article inspections, and adherence to quality agreements.
Monitor and improve supplier performance through KPIs, audits, and corrective action plans (8D, RCA).
Ensure robust risk management for supply chain quality, including preventive measures for critical components.
Operations Quality Management

Develop and maintain quality systems and processes across the entire manufacturing lifecyclefrom NPI to mass production.
Define and monitor Control Plans, PFMEA, and inline inspection processes to ensure consistent product quality.
Implement and analyze statistical process control (SPC) to drive process capability improvements.
Lead root cause analysis and corrective/preventive actions for production and field issues (0 km, warranty).
Support design-for-manufacturability (DFM) and design-for-quality (DFQ) activities during early development stages.
Drive quality improvement initiatives, customer satisfaction programs, and compliance audits.
Metrology Management

Define and oversee metrology strategy for NPI and production environments.
Ensure accurate measurement processes for complex opto-mechanical assemblies and components.
Lead inspection planning and utilization of advanced measurement techniques (CMM, optical measurement systems).
Support R&D and manufacturing teams with precision measurement, layout verification, and teardown analysis.

We are looking for a Design Quality Engineer.
Design Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for the Company. This is a key technical position, affecting part quality for both installed base and NPI products.
7In this role, you will
Daily duties include supporting the project team (R&D, SQA, Product, System and so on) during the development of a project. Our engineers review each design input and output deliverable throughout the development process and resolve compliance impediments as they arise. As a senior engineer the candidate will be responsible for defining two major evolving components in our work:
Implementing AI in our processes What are the regulatory requirements for implementing AI in a medical device and how to implement it in our development lifecycle.
Cybersecurity work instructions in compliance with the new FDA guidance, train the various teams on the guidance and its implications to our process, and establish best practices for supporting post market vigilance.

We are seeking a highly motivated and detail-oriented Production and Supplier Quality Team Leader .
This role is responsible for ensuring the
highest quality standards in production and supplier-provided components, driving continuous improvement, and maintaining compliance with
medical industry regulations.
In this role, you will
Lead and manage the Production & Supplier Quality team.
Develop and implement quality control processes for materials and products.
Collaborate with suppliers on quality agreements, audits, and corrective actions.
Oversee incoming inspections and ensure compliance with ISO 13485, FDA, MDR.
Drive continuous improvement using Six Sigma, Lean, RCA.
Conduct internal/external audits and manage CAPA, NCR, and risk documentation.
Mentor team members and foster a culture of quality excellence.