The Engineer II, Quality Control (QC), is responsible for all aspects of incoming and in-process quality planning, inspection, metrology, and incoming inspection operations. This role ensures the achievement of quality objectives, operational targets, and product quality requirements while serving as the subject matter expert for metrology development and issue resolution, including alignment between internal and supplier metrology processes.

The Engineer II, Quality Control (QC), plays a pivotal role in overseeing and improving supplier quality management processes. This position is responsible for ensuring that suppliers meet compliance standards and driving continuous improvements in their quality performance. The SQE will focus on monitoring, analyzing, and enhancing the quality of materials received, ensuring they meet organizational standards and customer requirements.

Your Responsibilities

Incoming Inspections

• 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.
• 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.
• Analyze and Report Quality Performance Data: Lead quality inspection performance data analysis, establish KPI metrics, and report findings to drive improvements.
• Execute Quality Projects and Tasks: Support and execute quality-related projects, tasks, and other activities as directed by the supervisor.

Supplier Quality Management

• Coordinate and work on the Supplier Selection process for new project development and qualification of new and or alternate supplier, to ensure that the right supplier is selected based on the defined requirements and specifications.
• Supports and or lead the conceptualized bill of materials creation together with relevant functions for new product development.
• Resolve supplier-related quality issues by ensuring timely and effective resolutions to maintain continuity of supply. Proactively collaborate with suppliers to identify opportunities for improvement, implement controls, and enhance the quality of received materials.
• Oversee Supplier Quality Management activities, including generating quality reports, conducting supplier assessments and qualifications, managing SCARs, reviewing supplier change notifications, approving first articles, maintaining supplier scorecards, and driving supplier development plans.
• Support suppliers change requests and qualification initiatives, including new parts, revisions, and tooling changes, to ensure seamless integration into the supply chain.
• Review and approve supplier control plans and inspection standards to ensure alignment with company quality objectives.
• Ensure timely resolution of supplier quality issues, including implementing corrective and preventive actions to address root causes effectively.
• Drive measurable improvement initiatives to enhance supplier performance, ensuring consistent excellence in supplier scorecards and quality metrics.
• Establish and maintain Supplier Quality Agreements, ensuring clarity in expectations and adherence to standards.
• Lead supplier audits (desktop, remote, or onsite) as part of the Global Supplier Audit program by developing comprehensive audit agendas, conducting thorough evaluations, preparing detailed supplier audit reports, and ensuring supplier adherence to quality and regulatory standards.
• Implement productivity improvement initiatives in collaboration with suppliers to enhance their quality output performance and improve the efficiency of incoming inspection processes.
• Collaborate with the Incoming QA team of inspectors and technicians to address incoming inspection issues and manage rejections by coordinating with suppliers to resolve non-conformances effectively.
• Plan and sustain the reduced incoming inspection activities by working closely with the suppliers to establish their outgoing inspection and monitor its performance.
• Provide key supplier performance metric updates to management, offering actionable insights into supplier and material quality performance.
• Support and execute quality-related projects and tasks as directed by the supervisor, ensuring alignment with organizational goals and objectives.
• May act as the strategic regional supplier quality representative to support BIOB and other BIOTRONIK sites.

Your Profile

• Technical / scientific degree at college / university level (mechanical, mechatronic engineering or equivalent)
• 5-7 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.
• Strong ability to interpret technical drawings and apply Geometric Dimensioning and Tolerancing (GD&T) principles effectively.
• In depth know-how of QMS regulations: ISO 13485, 21 CFR 820, ISO 14971, or applicable local regulations.
• ISO 9001/13485 auditor experiences or certification
• 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 Factor User experience is a plus

What we offer

• being encouraged to think and act entrepreneurially
• working in global teams and projects
• developing yourself professionally