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Christian Bürkert GmbH & Co. KG

Quality Planning & Supplier Development (New Product Introduction)

Reposted One Month Ago
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In-Office
Huntersville, NC, USA
Expert/Leader
In-Office
Huntersville, NC, USA
Expert/Leader
Lead the Advanced Product Quality Planning initiatives, align quality strategies with business growth, oversee NPI lifecycle and supplier quality, ensuring compliance with regulatory standards.
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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.

Christian Bürkert GmbH & Co. KG Huntersville, North Carolina, USA Office

Huntersville, United States

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