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Quality Planning & Supplier Development; Product Introduction

Job in Huntersville, Mecklenburg County, North Carolina, 28078, USA
Listing for: Burkert USA Corporation
Full Time position
Listed on 2026-06-18
Job specializations:
  • Engineering
    Quality Engineering, Regulatory Compliance Specialist, Process Engineer
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 100000 - 125000 USD Yearly USD 100000.00 125000.00 YEAR
Job Description & How to Apply Below
Position: 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/ISO
    14001, etc.)
  • Establish supplier performance metrics: supplier PPM, on‑time delivery, 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 (e.g., 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
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
  • Strate…
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