Manager of Quality Planning, Supplier Development, & New Product Introduction

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

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

Burkert Culture

Burkert USA Corp is a manufacturing and sales organization, that is family owned and was established in the US in 1984. Burkert employees enjoy an inclusive environment that's open to ideas and innovation for a growing company with opportunities for development. Work life balance is considered a priority with a comprehensive benefits package in place to support your personal and professional life.

• Medical, Dental, and Vision
• Short and Long-term Disability
• Life Insurance - Company paid and Additional Voluntary
• A great culture to grow with in your professional career
• 18 Days of PTO to start (PTO hours are earned per pay period and pro-rated based on date of hire)
• 12 Holidays according to annual company schedule and the employee birthday
• 401k with 6% Match (Variable included in match)
• Tuition Reimbursement (after 1 year)
• Full sized Gym (Huntersville)
• Many More!