Quality Engineer EU Operational Programs (m/f/d)

Reposted 20 Hours Ago
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Aachen, Nordrhein-Westfalen, DEU
In-Office
63K-98K Annually
Mid level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Ensure quality and regulatory compliance for facility management, infrastructure projects, and EHS. Manage documentation, CAPA/RCA, audits, SOPs, and interface with Engineering, Operations and global Quality to drive continuous improvement.
Summary Generated by Built In

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Environmental Health, Safety (EH&S) and Facilities Services (FS)

Job Sub Function:

Facilities Management & Planning

Job Category:

Professional

All Job Posting Locations:

Aachen, North Rhine-Westphalia, Germany

Job Description:

GERMAN

Stellenbeschreibung – Quality Engineer EU Operational Programs (m/w/d)

Überblick der Rolle

Der*die Quality Engineer EU Operational Programs (m/w/d) ist verantwortlich für die Schnittstelle zwischen den Abteilungen im Bereich EU Operational Programs und die Abteilung Quality Management. Zu diesem Bereich gehören die Abteilungen Facility Management, Infrastruktur Projekte und Arbeitssicherheit, Gesundheit und Umwelt (EHS). Die Rolle kombiniert technisches Verständnis mit Qualitäts- und Sicherheitskompetenz, um Compliance und kontinuierliche Verbesserung sicherzustellen.

Hauptaufgaben & Verantwortlichkeiten

1.       Sicherung von Qualitäts-Compliance in den Abteilungen Facility Management, Infrastruktur- und Bauprojekten und EHS (Environment, Health & Safety):

  • Qualitäts- und Compliance‑Begleitung technischer Betriebsprozesse (Versorgungstechnik, HLK, Reinräume, Druckluft, technische Gase, etc…).

  • Sicherstellung der Dokumentation und Nachverfolgung von Wartungs‑, Prüf‑ und Kalibrieraktivitäten gemäß interne SOPs und regulatorischen Anforderungen.

  • Bewertung technischer Störungen und Ableitung von CAPA‑Maßnahmen gemeinsam mit Quality, Engineering und Operations.

  • Sicherstellen, dass alle Facilities, Bau‑, Umbau‑ und Infrastrukturmaßnahmen den Qualitäts‑, GMP-, ISO- und internen Standards entsprechen.

  • Qualitätsanforderungen in Projektplanungen, Designspezifikationen und technischen Konzepten definieren und prüfen.

  • Unterstützung bei Audits und Behördeninspektionen.

2.       Dokumentation, Compliance & Prozessmanagement:

  • Erstellung und Pflege qualitätsrelevanter Dokumentationen (Quality Notes, Deviations, Non-Conformances, CAPAs, ….).

  • Erstellung, Pflege und kontinuierliche Verbesserung von SOPs, technischen Leitlinien, und Prüfplänen.

  • Sicherstellen der Einhaltung interner Standards, globaler Richtlinien und externer Vorschriften.

  • Mitwirkung an kontinuierlichen Verbesserungsprozessen und Lean‑/Six‑Sigma‑Aktivitäten.

3.       Untersuchungen & CAPA-Management

  • Durchführung technischer Root‑Cause‑Analysen bei Mängeln oder Störungen im Facility-, Bau- oder EHS‑Kontext.

  • Erstellen, Tracken und Bewerten von CAPAs sowie deren Wirksamkeitsprüfung.

  • Durchführen oder Begleiten von qualitätsbezogene Risikoanalysen und Gefährdungsbeurteilungen.

  • Förderung der Zuverlässigkeit durch systematische Lessons‑Learned‑Prozesse.

4.       Schnittstellenmanagement

  • Enge Zusammenarbeit mit Engineering, Facility Management, EHS, Produktion, externen Partnern und globalen Qualitätsfunktionen.

  • Sicherstellen einer klaren Kommunikation und eines strukturierten Informationsflusses in multidisziplinären Teams.

Qualifikationen & Anforderungen

Fachlich

  • Abgeschlossenes Studium im Bereich Ingenieurwesen (z. B. Versorgungstechnik, Gebäudetechnik, Umwelttechnik, Maschinenbau, Elektrotechnik) oder vergleichbare Qualifikation.

  • Erfahrung im Qualitätsmanagement, idealerweise in regulierten Industrien (MedTech, Pharma, Biotech, High-Tech).

  • Kenntnisse im Facility Management, Bauprojekten, technischer Gebäudeausrüstung oder Reinraumumgebung von Vorteil.

  • ausgeprägtes technisches Verständnis

  • Verständnis relevanter Normen/Regulatorien (z. B. ISO 9001, ISO 14001, ISO 45001, GMP).

  • Erfahrung mit CAPA, RCA, Change Control, Audits und Dokumentationssystemen.

Persönlich

  • Analytische Denkweise und ausgeprägte Problemlösungsfähigkeiten.

  • Starke Kommunikations- und Koordinationsfähigkeiten in interdisziplinären Teams.

  • Strukturierte Arbeitsweise, hohe Qualitätsorientierung und Verantwortungsbewusstsein.

  • Fähigkeit, technische Prozesse kritisch zu hinterfragen und nachhaltig zu verbessern.

  • Hohe Flexibilität und ausgeprägte Teamfähigkeit

Die erwartete Basisvergütung für diese Position beträgt 62.500 EUR bis 97.865 EUR.

ENGLISH

Job Description – Quality Engineer EU Operational Programs (m/f/d)Role Overview

The Quality Engineer EU Operational Programs (m/f/d) is responsible for the interface between the departments within EU Operational Programs and the Quality Management department. This includes Facility Management, Infrastructure Projects, and Environment, Health & Safety (EHS). The role combines technical understanding with quality and safety expertise to ensure compliance and continuous improvement.

Main Tasks & Responsibilities1. Ensuring Quality Compliance in Facility Management, Infrastructure/Construction Projects, and EHS
  • Quality and compliance support for technical operational processes (utilities, HVAC, cleanrooms, compressed air, technical gases, etc.).

  • Ensuring documentation and follow-up of maintenance, inspection, and calibration activities in accordance with internal SOPs and regulatory requirements.

  • Assessment of technical malfunctions and derivation of CAPA measures together with Quality, Engineering, and Operations.

  • Ensuring that all facilities, construction, renovation, and infrastructure measures comply with quality, GMP, ISO, and internal standards.

  • Defining and reviewing quality requirements in project planning, design specifications, and technical concepts.

  • Supporting audits and regulatory inspections.

2. Documentation, Compliance & Process Management
  • Creating and maintaining quality-relevant documentation (Quality Notes, Deviations, Non-Conformances, CAPAs, etc.).

  • Creating, maintaining, and continuously improving SOPs, technical guidelines, and test plans.

  • Ensuring compliance with internal standards, global guidelines, and external regulations.

  • Participation in continuous improvement processes and Lean/Six Sigma activities.

3. Investigations & CAPA Management
  • Conducting technical root cause analyses for deficiencies or malfunctions in Facility, Construction, or EHS contexts.

  • Creating, tracking, and evaluating CAPAs, including effectiveness checks.

  • Conducting or supporting quality-related risk analyses and hazard assessments.

  • Promoting reliability through systematic lessons-learned processes.

4. Interface Management
  • Close collaboration with Engineering, Facility Management, EHS, Production, external partners, and global quality functions.

  • Ensuring clear communication and structured information flow within multidisciplinary teams.

Qualifications & RequirementsTechnical
  • Completed degree in engineering (e.g., building services engineering, facility engineering, environmental engineering, mechanical engineering, electrical engineering) or equivalent qualification.

  • Experience in quality management, ideally in regulated industries (MedTech, pharma, biotech, high-tech).

  • Knowledge in facility management, construction projects, technical building equipment, or cleanroom environments is an advantage.

  • Strong technical understanding.

  • Understanding of relevant standards/regulations (e.g., ISO 9001, ISO 14001, ISO 45001, GMP).

  • Experience with CAPA, RCA, Change Control, audits, and documentation systems.

Personal
  • Analytical mindset and strong problem-solving skills.

  • Strong communication and coordination skills in interdisciplinary teams.

  • Structured working style, high quality orientation, and sense of responsibility.

  • Ability to critically question and sustainably improve technical processes.

  • High flexibility and strong team orientation.

The anticipated base pay range for this position is 62.500 EUR to 97.865 EUR.



Required Skills:



Preferred Skills:

Access Control (AC), Business Behavior, Conflict Resolution, Data-Driven Decision Making, Disruptive Innovations, Facility Management, Facility Management Software, Organizing, Premises Management, Proactive Behavior, Problem Solving, Project Reporting, Security Planning, Service Excellence, Standard Operating Procedure (SOP), Subject Matter Experts (SME) Collaboration

Skills Required

  • Completed degree in engineering (building services, facility, environmental, mechanical, electrical) or equivalent
  • Experience in quality management, ideally in regulated industries (MedTech, pharma, biotech, high-tech)
  • Strong technical understanding of building services and facility systems (utilities, HVAC, cleanrooms, compressed air, technical gases)
  • Understanding of relevant standards/regulations (ISO 9001, ISO 14001, ISO 45001, GMP)
  • Experience with CAPA, RCA, Change Control, audits and documentation systems
  • Creation and maintenance of quality documentation (Deviations, Non-Conformances, CAPAs, Quality Notes)
  • Support for audits and regulatory inspections
  • Analytical mindset, problem-solving, strong communication and coordination in interdisciplinary teams
  • Knowledge in facility management, construction projects, technical building equipment or cleanroom environments
  • Experience with Facility Management Software
  • Familiarity with Lean / Six Sigma continuous improvement methodologies
  • Skills listed under preferred: Access Control, Security Planning, Project Reporting, Organizing, SME collaboration, proactive behavior

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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