Quality Planning & Supplier Development - New Product Introduction

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.