Customer Quality Engineer

Reposted 12 Days Ago
Be an Early Applicant
Skopje, Skopski
Mid level
Healthtech • Biotech • Pharmaceutical
The Role
As a Customer Quality Engineer, you will lead quality tasks, drive risk management, monitor quality standards, and support product lifecycles in medical devices.
Summary Generated by Built In

Company Description

Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 12,000 employees and generated annual revenues in 2023 of around EUR 2bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

Job Description

Are you passionate about quality and innovation? We’re looking for a Customer Quality Engineer to support the product lifecycle of cutting-edge medical devices. You'll play a key role in risk management, validation activities, and ensuring top-tier quality for global manufacturing.

🔧 What You’ll Do:

  • Lead quality tasks across the product lifecycle
  • Drive risk management (ISO 14971, FMEA) and validation strategies
  • Collaborate with customers and cross-functional teams
  • Define and monitor quality standards, inspections, and supplier requirements
  • Support global sites during product transfers and validations

Qualifications

  • Degree in Engineering (Mechanical, Industrial, or similar)
  • 3+ years in a similar quality or regulatory role
  • Solid knowledge of ISO 13485, ISO 14971, 21 CFR 820
  • Experience with SAP, MS Office, and quality tools (FMEA, Six Sigma, etc.)
  • Strong problem-solving, communication, and teamwork skills
  • Fluent in English (A2/B1 or higher)

Additional Information

Why Join Us:

  • Innovate with Cutting-Edge Tech
  • Grow Professionally
  • Collaborative Culture
  • Impactful Projects
  • Competitive Compensation

Join us and be part of a forward-thinking team dedicated to innovation and excellence. Together, we will drive digital transformation and achieve remarkable results.

 

Top Skills

21 Cfr 820
Fmea
Iso 13485
Iso 14971
MS Office
SAP
Six Sigma
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The Company
HQ: Düsseldorf
2,246 Employees
On-site Workplace
Year Founded: 1864

What We Do

Gerresheimer is the global partner for pharma, biotech, healthcare and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging and drug delivery devices. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence, focus on quality and customers. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 10,000 employees and generates annual sales of more than €1.5 billion. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

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