Description

Summary / Position Purpose:

The Vice President of Quality is a senior executive responsible for leading the enterprise-wide Quality, Regulatory, and Compliance functions across all distribution and contract manufacturing division of TestEquity Group. This role ensures full compliance with applicable global supply chain and FDA regulations, QMS certification standards (such as ISO / AS / FDA) standards, internal controls, and customer-specific quality requirements while driving a culture of quality excellence, risk mitigation, and continuous improvement.

The VP of Quality will partner with executive leadership, Operations, and Finance to ensure robust quality systems, compliant manufacturing processes, and effective governance across all sites.

Essential Duties, Functions And/or Responsibilities

Quality Strategy & Executive Leadership

Develop and lead the quality and compliance vision, strategy, and roadmap aligned with corporate goals.
Collaborate with executive leadership to promote a culture of quality and continuous improvement.
Ensure robust documentation, control, and reporting of quality activities.
Ensure company-wide compliance with all relevant regulatory and industry standards.
Lead preparation for internal, customer, and third-party audits and inspections.
Develop and implement a comprehensive quality strategy aligned with business objectives.
Oversee the development and execution of quality policies, systems, and procedures, including quality assurance (QA) programs across operations, manufacturing, product development, and service delivery.
Develop and manage the budget for the quality and compliance department, ensuring effective use of resources.

Quality Management System (QMS) & ISO Compliance

Implement and maintain effective QMS in compliance with applicable standards (e.g., ISO 9001, ISO 17025, ISO 13485, FDA, GMP, AS91X0).
Ensure successful QMS certification, surveillance, and recertification audits across all distribution, contract manufacturing and support locations as organization’s Management Representative.
Oversee the maintenance of quality documentation, ensuring accuracy and availability for audits and inspections.
Establish governance over document control, change management, training, and record retention systems.
Champion Management Review processes
Lead root cause analysis and corrective action planning for quality issues.
Partner with customer service and operations to resolve quality issues.
Monitor customer feedback and quality KPIs to improve product/service quality through the implementation of metrics and dashboards to monitor product and service quality performance.

Manufacturing & Process Quality

Collaborate with production and departments to ensure quality standards are integrated into all manufacturing processes.
Oversee the maintenance of product quality control documentation, ensuring accuracy and availability for audits and inspections.
Oversee process validation, control plans, PFMEA, SPC, as required.
Partner with Manufacturing Engineering on NPI, design for manufacturability (DFM), and design for quality (DFQ).
Lead root cause analysis and corrective actions for internal defects, field failures, and customer returns.

Supplier Quality & Customer Compliance

Lead supplier quality strategy, including supplier qualification, auditing, scorecards, and continuous improvement.
Ensure suppliers meet ISO, FDA, and customer-specific quality and regulatory requirements.
Serve as the executive point of contact for key customer quality escalations and audits.
Drive reduction in cost of poor quality (COPQ), scrap, rework, and warranty exposure.

Metrics, Risk Management & Reporting

Define and track enterprise quality KPIs, including yield, defect rates, audit findings, customer complaints, and cost of quality.
Lead risk-based assessments related to product quality, regulatory exposure, and operational compliance.
Provide regular quality and compliance reporting to executive leadership and, as required, the Board of Directors.
Directly and indirectly responsible for product quality.
Other duties as assigned.

Qualifications

Education and/or Work Experience Requirements:

Bachelor’s degree in Engineering, Manufacturing, Quality, or a related technical field required.
Master’s degree or MBA preferred.
12+ years of progressive quality leadership experience in electronic manufacturing or EMS environments.
5+ years in a senior leadership role (Director, Senior Director, or VP).
Demonstrated experience leading ISO-certified and FDA-regulated Quality Management Systems.
Multi-site and global manufacturing leadership experience is strongly preferred.

Certifications (Preferred)

ASQ certifications (CMQ/OE, CQE, CQA)
Lead Auditor certification
Lean Six Sigma Black Belt or Master Black Belt

Skills & Competencies

Deep expertise in ISO, FDA QSR, and AS compliance frameworks.
Strong understanding of manufacturing processes and quality risks.
Executive-level communication and stakeholder management skills.
Data-driven decision making and advanced problem-solving capabilities.
Ability to lead through change in fast-paced, regulated manufacturing environments.

Physical Requirements

Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards
Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state, and local standards

This position requires applicants to be authorized to work in the US without sponsorship; TestEquity does not sponsor applicants for work visas.

TestEquity provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

TestEquity LLC

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