Lead Engineer, Quality Control

Lead Engineer, Quality Control

As one of the world´s leading manufacturers of cardio
- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

The Lead, QC, supports and drives compliance initiatives and continuous improvement efforts to enhance the quality performance of incoming, in-process, and final acceptance inspections. The role requires close collaboration with cross-functional teams to align and sustain effective product quality management practices.

**Your Responsibilities**
- Lead the QC Inspection Team: Provide leadership to ensure the team achieves product quality performance and operational goals.
- Optimize Resource Deployment: Allocate inspection resources effectively to meet operational requirements and maintain productivity.
- Ensure Process Compliance: Oversee inspection and operational processes to ensure adherence to established procedures, work instructions, drawings, and specifications.
- Develop Test Specifications and Programs: Create test specifications and measurement programs for geometric and non-geometric tests, including material testing devices (e.g., tensile-testing).
- Support Fixture and Jig Design: Collaborate with internal and external service providers to design and construct fixtures and jigs, including concept development and requirement specification creation.
- Validate Measurement Procedures: Perform method validation and verification of measurement procedures in compliance with existing regulations and guidelines, including conducting GR&R (Gauge R&R) and process capability studies.
- Manage Test Equipment Selection and Procurement: Identify appropriate measuring and test equipment and support the procurement process to meet operational needs.
- Integrate Testing Systems: Implement data transfer of measuring and testing devices into the SAP QM system, ensuring seamless interface support as required.
- Coordinate Supplier Measurement Strategy: Collaborate with Supplier Management to align on measurement strategies with suppliers to ensure consistency and compliance.
- Streamline Incoming Material Processing: Ensure timely processing of incoming materials by optimizing inspection activities for efficiency and accuracy.
- Manage Non-Conforming Materials: Oversee incoming rejection processes for non-conforming materials, monitor aging periods, and implement actions to minimize delays and inventory impact.
- Collaborate on Inspection Requirements: Work with the quality or engineering team to define incoming inspection and metrology requirements for new products and raw components.
- Monitor Team Performance: Track the QC Inspection Team's performance, address issues proactively, and ensure continuous improvement.
- Analyze and Report Quality Performance Data: Lead quality inspection performance data analysis, establish KPI metrics, and report findings to drive improvements.
- Drive Supplier Quality Improvements: Partner with the Supplier Quality Management team to investigate material failures, conduct root cause analysis, and implement improvements for incoming material quality.
- Develop and Manage the QC Team: Provide guidance, coaching, and support to QC inspectors, assigning responsibilities and driving improvement initiatives and projects.
- Support Team Development: Offer leadership and coaching to direct reports, conduct performance assessments, and establish individual development plans to foster growth.
- Provide Key Metrics to Management: Update management on performance metrics and quality inspection outcomes, offering insights for decision-making.
- Execute Quality Projects and Tasks: Support and execute quality-related projects, tasks, and other activities as directed by the supervisor.

**Your Profile**
- Technical / scientific degree at college / university level (mechanical, mechatronic engineering or equivalent)
- At least eight to ten years of relevant experience in Quality Control, preferably within a regulated environment.
- Expert knowledge in quality inspection techniques, quality tools, failure mode analysis, and extensive experience in handling measuring instruments.
- Proven experience in calibrating and maintaining quality control equipment to ensure accuracy and reliability.
- Familiarity with metrology equipment, including Coordinate Measuring Machines (CMM), Smart Scope, Height Gage, Vernier Calipers, Digital Micrometers, measuring tapes, protractors, thread plug gages, and Profile Projectors.
- Statistical methods
- Technical knowledge and experience to work effectively with cross functional teams. (Operations, R&D, Facility Management, HR, Procurement, Finance), is preferred.
- Good communication skills with people from all levels in the organization.
- SAP and Success