Quality Manager

Goodfellow; Columbia (MD); On-site; USD 110,000 - 165,000; Full time

Job summary

Goodfellow in Columbia, MD is seeking an experienced Quality Manager to lead the quality function at the site, owning ISO 13485 and AS9100 QMS. You will conduct gap analyses, redesign processes, and drive re-certification while developing a team of Quality Engineers and QC staff.

You will collaborate with Operations, Engineering, and Supply Chain to embed quality upstream, manage CAPA, audits, and metrics, and report to senior leadership on quality performance.

Qualifications

• Bachelor's degree in Engineering, Quality, or related field.
• 7+ years of progressive quality management experience in a regulated manufacturing environment.
• Hands-on experience implementing or overhauling ISO 13485 and/or AS9100 QMS.
• Demonstrable experience leading teams through external certification or recertification audits.
• Strong working knowledge of CAPA, root cause analysis (8D, 5-Why, fishbone), FMEA, SPC, MSA.

Responsibilities

• Lead gap analysis and redevelop QMS for ISO 13485 and AS9100.
• Own CAPA, internal audits, risk management, and supplier quality.
• Mentor Quality Engineers and Inspectors; manage teams.
• Partner with Operations, Engineering, and Supply Chain to embed quality upstream.
• Prepare audit-ready documentation and report metrics to leadership.

Skills

CAPA

Root cause analysis

8D

5-Why

Fishbone

FMEA

SPC

MSA

Leadership

Communication

Education

Bachelor's degree in Engineering/Quality or related field

Tools

ERP software

Electronic document control systems

Job description

Founded in London in 1946, Goodfellow is a global leader in advanced materials, enabling innovation globally across high-tech sectors including aerospace, medical research, electronics, and green energy. With a portfolio of more than 170,000 specialist products, we support scientists, engineers, and manufacturers worldwide in transforming ideas into real world solutions.

Today, the Goodfellow Group combines global reach with deep materials expertise. Operating from key hubs across Europe, the United States, and China, we provide advanced materials, precision engineering, and world-class testing capabilities to organisations at the forefront of research and technology. Backed by Battery Ventures, we continue to invest in growth through international expansion and strategic acquisitions.

Our operations are centred around three key manufacturing and scientific hubs:

Huntingdon, Cambridgeshire (UK) – Our headquarters and Advanced Materials Centre, where more than 170,000 advanced materials and reference standards are stocked, processed, and distributed to customers worldwide.

Baltimore, USA – Our Precision Engineering Centre, an advanced laser microfabrication and manufacturing facility delivering highly specialised engineering solutions.

Switzerland – Our Swiss Competence Centre, providing world-leading materials testing, characterisation, and analytical capabilities.

In addition, we maintain sales offices in Pittsburgh (USA) and Shanghai (China), ensuring close support for customers in key global markets.

Across the Goodfellow Group, we are united by a commitment to technical excellence, collaboration, and sustainable innovation. Whether your passion lies in science, engineering, technology, or business, you’ll find opportunities here to develop your career while helping shape the future of advanced materials.

About the Role

We are seeking an experienced Quality Manager to lead the quality function at our Site in Columbia. This is a hands‑on leadership role responsible for owning and developing our ISO 13485 (Medical Devices) and AS9100 (Aerospace) Quality Management Systems. The successful candidate will conduct a full gap analysis of the current QMS, redesign processes and documentation to close conformance gaps, and lead the site through re-certification while managing a team of Quality Engineers and QC/Inspection staff.

You will report to the US President for site requirements but also to the Global Quality and Regulatory Manager based in Switzerland

This is a high-visibility, high-impact position ideal for a quality leader who thrives on building and developing systems, not just maintaining them.

Key Responsibilities

QMS Ownership

• Conduct a comprehensive audit and gap assessment of the existing ISO 13485 and AS9100 quality management systems against current standard requirements
• Develop and execute a roadmap, prioritizing critical nonconformances and certification risks
• Rewrite/update quality manuals, procedures, work instructions, and forms to ensure full conformance and practical usability on the shop floor
• Lead internal readiness reviews and coordinate with certification bodies for surveillance and recertification audits
• Develop and maintain document control, records management, and change control processes

Quality Systems & Compliance

• Own core QMS processes: CAPA, nonconforming material/product, internal audits, management review, supplier quality, risk management, and design controls (as applicable)
• Ensure compliance with applicable regulatory requirements (e.g., FDA 21 CFR Part 820, EU MDR where relevant) alongside ISO 13485 and AS9100
• Drive root cause analysis and corrective action effectiveness across the site
• Own and report site-level quality metrics (scrap, rework, escapes, audit findings, CAPA aging, on‑time delivery quality) to leadership
• Manage, mentor, and develop Quality Engineers, QC Inspectors, and inspection technicians
• Define roles, responsibilities, and workload allocation across incoming, in-process, and final inspection functions
• Build team capability in root cause analysis, statistical methods, and quality tools (8D, FMEA, SPC, MSA)
• Set performance objectives and conduct regular reviews for direct reports

Cross-Functional Collaboration

• Partner with Operations, Engineering, and Supply Chain to embed quality at the source and reduce reliance on end‑of‑line inspection
• Support new product introduction (NPI) and first article inspection (FAI/AS9102) activities
• Act as the site's primary quality representative in customer and regulatory audits

Required Qualifications

• Bachelor's degree in Engineering, Quality, or a related technical field (or equivalent experience)
• 7+ years of progressive quality management experience in a regulated manufacturing environment
• Direct, hands‑on experience implementing or significantly overhauling an ISO 13485 and/or AS9100 quality management system (not just maintaining an existing mature system)
• Demonstrable experience leading teams through external certification or recertification audits
• Strong working knowledge of core quality tools: CAPA, root cause analysis (8D, 5-Why, fishbone), FMEA, SPC, MSA
• Demonstrable people leadership experience managing Quality Engineers and/or QC/Inspection staff
• Excellent written communication skills — able to produce clear, audit-ready documentation
• Experience with FAI/AS9102 (for aerospace scope) and/or design controls and risk management per ISO 14971 (for medical device scope)

Preferred Qualifications

• Lead Auditor certification (ISO 13485 and/or AS9100)
• ASQ certification (CQE, CQM/OE, or CMQ/OE)
• Experience in one or both aerospace and medical device manufacturing environments.
• Familiarity with FDA QSR / 21 CFR Part 820 and/or EASA/customer-specific aerospace quality requirements
• Experience with ERP/QMS software platforms and electronic document control systems