Quality Manager at AHEAD

Libertyville, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Manufacturing, Electronics, Medical DevicesIndustries

Requirements

Bachelor's degree in Engineering, Quality, or related technical discipline (Master’s degree a plus)
Minimum 5–8 years of experience in quality management in a technology or electronics manufacturing environment, preferably with exposure to medical devices
In-depth knowledge of ISO 9001 and ISO 13485 standards; ASQ certifications (e.g., CQE, CQM/OE) preferred
Experience with FDA regulatory requirements and medical device compliance (21 CFR 820) is a strong plus
Proficiency in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA, 8D)
Strong understanding of statistical process control (SPC) and data analysis
Excellent project management, communication, and cross-functional collaboration skills
Experience leading audits and representing the company during regulatory or customer inspections
Strong experience with CAPA, root cause analysis, risk management, and design control
Proficiency with quality tools: FMEA, 5 Whys, Ishikawa, DOE, SPC, etc
Working knowledge of regulatory requirements such as FDA 21 CFR Part 820 (for medical devices)
Proficiency in quality data analysis and reporting tools (e.g., Minitab, Excel, SPC software)
Excellent communication and documentation skills
Certifications such as CQE, CQA, or Six Sigma (a plus)
Familiarity with risk management principles (ISO 14971)
Experience with ERP systems and electronic document management systems (eDMS)
Analytical thinking and problem-solving
Attention to detail and a high degree of accuracy
Cross-functional collaboration
Decision-making and strategic thinking
Strong leadership skills

Responsibilities

Maintain and continuously improve the company’s QMS in compliance with ISO 9001 and ISO 13485 standards
Ensure that quality objectives are established, tracked, and met across departments
Lead internal audits and manage external audits by customers, registrars, and regulatory agencies
Oversee document control, CAPA, non-conformance, and risk management processes
Ensure compliance with applicable regulatory requirements (e.g., FDA 21 CFR Part 820 for medical devices)
Manage regulatory inspections and certification audits
Develop and enforce procedures and policies that support compliance
Drive root cause analysis and implement effective corrective/preventive actions (CAPA)
Work closely with Engineering, Production, and Supply Chain to ensure product quality from design to shipment
Manage incoming, in-process, and final inspection processes
Lead initiatives to reduce scrap, rework, and returns
Develop and maintain supplier quality performance metrics
Conduct supplier audits and qualification
Collaborate with suppliers to resolve quality issues and drive continuous improvement
Lead and develop the Quality Team, including QA Engineers, Technicians, and Inspectors
Foster a culture of quality, compliance, and continuous improvement across the organization
Provide quality training to cross-functional teams
Other job duties as assigned

Skills

ISO 9001

ISO 13485

QMS

CAPA

Root Cause Analysis

Internal Audits

Document Control

Risk Management

FDA 21 CFR Part 820

Supplier Audits

Quality Training

AHEAD

Digital transformation and cloud consulting services

About AHEAD

AHEAD specializes in digital transformation services, focusing on helping medium to large enterprises modernize their IT infrastructure. The company offers a range of services including cloud migration, automation, and infrastructure optimization, primarily using Microsoft Azure. AHEAD's products work by providing tailored consulting and managed services that guide clients through the complexities of digital transformation. What sets AHEAD apart from its competitors is its deep expertise in cloud solutions and a strong client-centric approach, which has been validated by achieving Gold Cloud Platform Competency with Azure. The company's goal is to empower organizations to take control of their digital transformation journeys and achieve sustainable success.

Chicago, IllinoisHeadquarters

2007Year Founded

BUYOUTCompany Stage

Consulting, Enterprise SoftwareIndustries

1,001-5,000Employees

Benefits

Health Insurance

401(k) Retirement Plan

Paid Vacation

Paid Sick Leave

Risks

Emerging cloud service providers offer similar services at lower costs.

Rapid technological advancements may outpace AHEAD's solution updates.

Economic downturns could reduce spending on digital transformation projects.

Differentiation

AHEAD specializes in digital transformation with a focus on cloud solutions.

The company achieved Gold Cloud Platform Competency with Microsoft Azure.

AHEAD offers tailored solutions for cloud migration and infrastructure optimization.

Upsides

Increased demand for hybrid cloud solutions aligns with AHEAD's expertise.

Growing interest in AI-driven IT operations presents new opportunities for AHEAD.

The rise of edge computing offers AHEAD opportunities in edge-to-cloud solutions.

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