Job Description

Senior Engineer, Supplier Quality Management
As one of the worldxc2xb4s 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 Senior Engineer, Supplier Quality Management, 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.
In this role, the Senior Engineer, Supplier Quality Management will collaborate closely with cross-functional teams, including procurement, production, and engineering, to ensure alignment on supplier quality objectives and initiatives. This includes developing and implementing robust supplier quality management processes, conducting supplier assessments and audits, and fostering partnerships to address quality gaps effectively.
The Senior Engineer, Supplier Quality Management will also lead efforts to establish consistency in the execution of supplier quality activities across departments/functions. Key responsibilities include driving root cause analysis, implementing corrective and preventive actions for supplier-related issues, and supporting the qualification of new suppliers and materials.
This role demands strong problem-solving skills, effective communication, and a proactive approach to achieving supplier quality excellence and fostering a culture of continuous improvement.
Your Responsibilities

• 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, biomedical, polymer engineer-ing, natural sciences)
• At least five to seven years' work experience in a regulated environment (medical devices/life science/pharmaceutical industry)
• 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
• The ability to foster a productive team-oriented environment, handling multiple assignments, and flexibility in responding to an environment with rapidly priorities shifting/changes is preferred.
• Well-developed problem-solving skills, excellent verbal and written communication skills, and the ability to listen, learn, teach, and think strategically are traits that are required for long term success in this role.
• Technical knowledge and experience to work effectively with cross functional teams. (Operations, R&D, Facility Management, HR, Procurement, Finance), is preferred.
• Experience in injection/extrusion molding process is a plus.
• Familiarity with metrology equipment, including Coordinate Measuring Machines (CMM), Smart Scope and Profile Projectors is a plus
• Desktop applications, analytical tools, presentations, document management.
• Documents and Records lifecycle management experiences 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

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.
Location: Singapore| Working hours: Full-time
Apply now under: www.biotronik.com/careers
Job ID: 60179 | Contact: Human Resources
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.