| Location | Huntersville, NC |
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:
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.