Quality Inspector I

Job Overview

Position: Quality Inspector (Contract, 15 months with potential for permanent) in Aachen, North Rhine-Westphalia, Germany.

Responsibilities

• Conduct inspections, tests, and reviews of quality documents such as Device History Records and sampling procedures for incoming materials, parts/components, and partially assembled or finished medical devices.
• Support Engineering and Operations as needed.
• Perform inspections of purchased parts, assemblies, or finished products using defined criteria and standard visual, physical, mechanical, and/or electrical measurement methods.
• Visually inspect large lots of complex components under a microscope.
• Carry out mechanical testing with advanced inspection systems, including optical (vision) and tactile measurement systems.
• Document inspection and test results to determine acceptance or rejection of components.
• Perform and document process and system audits based on established procedures.
• Maintain all document‑controlled records and inspection records accurately and in a timely manner.
• Coordinate calibration of inspection instruments and fixtures.
• Enter data into relevant systems (SAP skills preferred).
• Monitor critical equipment and instruments to ensure proper operation and calibration.
• Assist in developing or revising SOPs, test procedures, protocols, and checklists; support engineers in improving inspection processes.
• Identify and evaluate problems and develop initial recommendations for corrective actions.
• Communicate business‑relevant issues or improvement opportunities to higher management.
• Ensure compliance with company health, safety, and environmental policies.
• Undertake additional assigned tasks.

Experience & Education

High school diploma or equivalent required; Associate degree in a technical field preferred.

At least 8 years of experience in quality inspection; experience in medical device industry preferred.

Required Knowledge, Skills, and Competencies

• Excellent German communication skills, both written and verbal.
• Strong ability to perform complex mechanical testing, including support of engineering in troubleshooting, fixture design, set‑ups, and quality plans.
• Experience with modern mechanical test systems (vision and tactile measurement).
• Electrical and optical testing of cables and sensors.
• Knowledge of Geometric Dimensioning & Tolerancing (GD&T).
• Familiarity with IPC‑610.
• Proficiency in using all test equipment, electrical test instruments, and microscopes.
• Understanding of ISO, GMP, US FDA 21 CFR QSR, and ISO 13485.
• Attention to detail and adherence to SOPs and test procedures.
• Strong mathematical skills and communication competence.
• Knowledge of Lean, Six Sigma, Kaizen, and continuous improvement.
• Ability to work independently and meet deadlines without supervision.
• Adaptability to changing business requirements and priorities.
• SAP knowledge and Microsoft Office proficiency are advantages.

Benefits

Competitive base salary in the range €33,400 – €54,625.

Annual bonus with target based on pay grade and location, and sales commissions.

Vacation days, 12‑week parental leave, bereavement, caregiver, volunteer leave, and well‑being reimbursement.

Programs for financial, physical, and mental health; service‑anniversary and recognition awards.

Eligibility for various insurance plans subject to location and plan terms.