Quality Planning & Supplier Development Lead

Burkert USA Corp · Huntersville, North Carolina

FULL TIME

Job Description

Position Title:

Quality Planning & Supplier Development Leader (New Product Introduction)

Department:

Quality

Core Industry:

Biopharma/Lab & Medical/Food & Beverage/Energy

Reports to:

VP Quality/EHS/Regulatory Compliance

Location

Huntersville, NC

(Position has ability to work onsite 3 days and remote 2 days depending on business need)

Summary

The Leader of Quality Planning, New Product Introduction (NPI) & Supplier Development is responsible for leading quality strategy across the full product lifecycle, with a focus on new product introduction, supplier quality development, and Quality Management System (QMS) integration within biopharma, lab and analytical and medical applications.

This role ensures robust quality planning, supplier capability development, regulatory compliance, and seamless industrialization of product. The Manage will drive a proactive, data-driven quality culture across internal operations and the external supply base to support scalable growth, innovation, and operational excellence.

Key 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

You may be asked to do other responsibilities as they come up filler*

Qualifications/

Experience

Experience with leadership and responsibilities that are required

Bachelor’s degree in engineering, Quality, or related field (master’s preferred)

Six Sigma Green or Black Belt certified (a plus)

5-7+ 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

Company	Burkert USA Corp
Location	Huntersville, North Carolina
Type	FULL TIME
Niche	Full-time

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