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Christian Bürkert GmbH & Co. KG

Quality Planning & Supplier Development (New Product Introduction)

Reposted 15 Days 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.
The summary above was generated by AI

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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