Quality Planning & Supplier Development (New Product Introduction)

Bürkert

  • Huntersville, North Carolina
  • 30+ days ago

    Highlights

    Develop supplier capability through Process audits, technical assessments, and Quality System evaluations (ISO 9001/ISO14001, etc.). Lead quality execution across the NPI lifecycle: concept, design, validation, launch, post-launch monitoring.

    Numbers & Facts

    LocationHuntersville, North Carolina

    Description

    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.

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