About this role
Where would you like to shape the success of your future career: At a worldwide leading manufacturer of process measuring and control technology? In a family- owned company that values its more than 3,700 employees in more than 30 countries and sees them all as individuals? In a team that breaks new ground with courage and passion?
Did you answer „Yes“ three times? Then it is time for us to make your acquaintance.
RESPONSIBILITIES:
• Establish and lead Advanced Product Quality Planning (APQP) frameworks tailored for regulated industries • Define quality strategies aligned with business growth and new market expansion • Drive risk-based methodologies (FMEA, CTQs, control plans) across product and process development • Align internal and supplier quality expectations with customer and regulatory requirements • Lead quality execution across the NPI lifecycle: concept, design, validation, launch, post-launch monitoring • Ensure robust design transfers into manufacturing and supply chain • Oversee: • Design controls and technical reviews • Process validation (IQ/OQ/PQ) • First Article Inspection (FAI) and PPAP (as applicable)
• Drive Right First Time (RFT) and First Pass Yield (FPY) for new product launches • Develop and execute a strategic supplier development program aligned with business growth and NPI requirements • Lead supplier engagement early in NPI to ensure: • Design for manufacturability (DFM) • Process capability and scalability • Risk mitigation in critical components
• Establish supplier segmentation and performance management • Strategic, critical, and transactional suppliers
• Drive supplier qualification and onboarding processes including: • Audits and capability assessments • Process validation alignment (IQ/OQ/PQ where applicable)
• Implement supplier quality tools: • Supplier APQP • PPAP/FAI • Supplier FMEA and control plans
• Lead supplier performance improvement initiatives based on: • Supplier PPM • On-time delivery • Cost of Poor Quality (COPQ)
• Drive First Article Inspection (FAI) and PPAP development. • Lead qualification and onboarding of new suppliers aligned with NPI timelines. • Develop supplier capability through Process audits, technical assessments, and Quality System evaluations (ISO 9001/ISO14001, etc.) • Establish supplier performance metrics: Supplier PPM, On-time Delivery, Cost of Poor Quality (COPQ) • Partner with Supply Chain to develop long term supplier partnerships and dual sourcing strategies • Drive corrective actions and continuous improvement with suppliers using structured methodologies (8D, DMAIC) • Ensure NPI and supplier development processes are fully integrated into the QMS and aligned with: • ISO 9001 • ISO 13485 • FDA regulations (be, 21 CFR Part 82)
• Standardize and enforce procedures: • Design control • Supplier quality management • Change management (including supplier changes) • CAPA processes
• Ensure audit readiness across internal operations and supplier base • Ensure compliance across core industries (Biopharma, Lab & Medical) • Collaborate with Regulatory Compliance teams on: • Product and material compliance (RoHs, REACH, CMRT,PFAS considerations) • Supplier regulatory requirements and documentation
• Monitor evolving regulatory requirements impacting products and suppliers • Lead collaboration across: Engineering, Manufacturing & Operations, Supply Chain & Procurement and Regulatory Compliance • Integrate suppliers into the broader ecosystem strategy (Technology, Service, Innovation Collaborators) • Support co-development initiatives with key suppliers and customers • Manage and co-develop ecosystem approach through affiliations and regulators to drive core industry focus markets
*This job description indicates the general nature and level of work expected. It is not designed to cover and contain a comprehensive listing of activities, duties or responsibilities required by the employee. Employee may be asked to perform other duties as required.*
REQUIREMENTS:
• Bachelor’s degree in engineering, Quality, or related field (master’s preferred) • Six Sigma Green or Black Belt certified (a plus) • 10+ years in Quality Assurance within manufacturing environments • Experience in regulated industries preferred: Pharma/Biotech, Food & Beverage, Lab & Analytical/Medical Devices • APQP, PPAP, FMEA, Control Plans • Root cause analysis (8D, 5 Whys, Fishbone) • Statistical analysis and digital quality systems (SPC, Cp/Cpk) • Quality Management Systems (ISO 9001/ISO 13485- a plus) • Supplier auditing and development • Risk management frameworks • Strong project management and program skills • Strategic/data driven decision making
In return, we offer you exciting and challenging responsibilities, diverse perspectives with a high degree of individual freedom and a corporate culture that encourages you to use it.
Curious? Then we look forward to receiving your application.