Customer Quality Engineer at Gerresheimer

Skopje, Centar Municipality, North Macedonia -

Full Time

Start Date

Immediate

Expiry Date

08 Feb, 26

Salary

0.0

Posted On

10 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Engineering, Quality Management, Risk Management, Validation, ISO 13485, ISO 14971, 21 CFR 820, SAP, MS Office, FMEA, Six Sigma, Problem Solving, Communication, Teamwork, Medical Devices, Customer Collaboration

Industry

Machinery Manufacturing

Description

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.

Responsibilities

The Customer Quality Engineer will lead quality tasks across the product lifecycle, drive risk management and validation strategies, and collaborate with customers and cross-functional teams. This role is essential for defining and monitoring quality standards and supporting global sites during product transfers and validations.