Supplier Quality Engineer Medical Devices

Are you a skilled Quality Engineer eager to make a real difference in the world of medical tech? Join our innovative team at Boeblingen where we create state-of-the-art medical solutions that are propelling healthcare to new frontiers. As a crucial member of our forward-thinking company, you’ll work on exciting projects that challenge your skills and expand your expertise, all while contributing to the digital transformation of prestigious organizations. If you’re passionate about technology, thrive in a collaborative environment, and are ready to take your career to the next level, we want to hear from you!

Key Responsibilities:

• Implement Quality Engineering, Purchasing Controls, and Supplier Quality processes related to the development, procurement, and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices, products, or services.
• Evaluate suppliers; critical quality processes and ensure compliance with regulatory requirements and procedures.
• Drive supplier improvement via SQIPs (Supplier Quality Improvement Plans) and lead the Supplier Change Notice process with support from Engineering, Quality Engineering, Assurance, qualify suppliers, assess their metrics, and audit their critical quality processes.
• Ensure validations are completed where specified and control plans exist to ensure sustained quality and compliance of supplied raw materials and components.
• Independently produce and complete Supplier Quality Engineering activities and documentation.
• Complete qualification of materials and components (including spare parts), develop/improve supplier processes for CtQ's, and ensure supplied parts meet specifications and control limits/tolerances for CtQ parameters.
• Qualify and sustain sub-processes of suppliers, including performing process audits and ensuring components/products are released according to specifications and quality requirements (APQP/PPAP), and SQ audit results.
• Manage SCAR processes, ensuring effective and timely closure, and lead process improvement methodologies and organizational change management.
• Develop and support regulatory compliance gaps at suppliers, including quality system and process development activities.
• Manage supplier status changes on the Approved Supplier list.
• Ensure raw materials, components, and products at suppliers are released according to requirements.
• Perform third-party product compatibility risk assessments in partnership with R&D and Market Procurement (Markets SQE).
• Drive quality and compliance development and/or improvement at suppliers when needed.

Required Skills and Qualifications:

• Bachelor’s degree in engineering or science discipline, or equivalent experience.
• 4 to 8 years of experience in establishing and maintaining regulated quality for raw materials, components, and finished products.
• Certification with recognized accreditation bodies (e.g., RAB-QSA / IRCA) or successful completion of ASQ CQE certification; Quality will be an advantage.
• Auditor (CQA) or Certified Biomedical Auditor, or completion of a recognized Lead Auditor course is an advantage.
• Excellent communication skills in English (written and verbal).
• Experience in collaborative environments, conflict resolution, and stakeholder influencing.
• Ability to drive progress, take initiative, and achieve results.
• Experience with technical drawings and specifications.
• Experience in manufacturing processes such as welding, soldering, crimping, injection molding, plating, casting, and thermal forming.
• Experience with APQP (IQ, OQ, PQ) is preferred.
• Technical writing skills for protocols and reports.
• Knowledge of ISO 9001, 13485 is a plus.
• Ability to travel to supplier sites within the region.
• Ability to communicate with local suppliers in their native language.