Quality Planning & Supplier Development (New Product Introduction)
Bürkert Group
- # Quality Planning & Supplier Development (New Product Introduction)Applylocations: Huntersvilletime type: Full timeposted on: Posted 5 Days Agojob requisition id: JR\_00001174**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 makingIn 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.**
- J-18808-Ljbffr Bürkert Group
Vacancy posted 2 days ago
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