Engineer, Quality Engineering

AMO Groningen is recruiting a QA Engineer, located in Groningen.

The QA Engineer ensures that systems and equipment within the Mechanical and Optical Laboratory (MO Lab) are adequately maintained and remain in a compliant state. The QA Engineer contributes to the development of high-quality products by developing and improving laboratory testing methods. The role involves close collaboration with R&D, QA, and Technical Services, and supports non-conformance and CAPA processes.

Key Responsibilities:

• Evaluate compliance with applicable laboratory standards and procedures;
• Act as a Subject Matter Expert (SME) during projects, regulatory, medical device (MD), and notified body audits and inspections;
• Improve and maintain laboratory procedures;
• Specify, develop, and improve test method validations, including writing protocols and reports;
• Write and develop IQ and TMV protocols and reports for new and existing laboratory equipment;
• Act as a project leader for laboratory-related projects;
• Participate, when necessary, in cross-functional projects and activities;
• Coordinate non-routine laboratory testing activities, including validation testing;
• Manage internal audit observations, Non-conformance and CAPA records from initiation through full cycle completion and final approval;
• Make recommendations to improve product quality, efficiency, cost, processes, and productivity techniques;
• Support day-to-day laboratory troubleshooting for test equipment and unexpected test results;
• Gather and analyze test result data;
• Lead Cost Improvement (CIP) projects

Qualifications

Education:

Bachelor or Master degree preferably in mechanical engineering, optical engineering mechatronics, and relevant technical disciplines.

Experience and Skills:

Minimum of 4 years of related experience within Pharmaceutical and/or Medical Device companies.

Other:

• Advanced, broad, and in-depth knowledge of laboratory testing and automation;
• High level of accuracy and attention to detail;
• Strong troubleshooting and analytical skills;
• Strong planning skills with the ability to prioritize multiple commitments and solve technical problems;
• Good interpersonal skills, with the ability to engage effectively with personnel at all organizational levels;
• Writing skills, ability to create protocols, reports, business correspondence, and procedures;
• Proactive and able to work independently,
• Skilled to develop and present new or improved test methods and solve laboratory problems in a timely manner;
• Fluent in Dutch and English;
• Ability to work with various measuring equipment.

Fully Onsite

Location: Groningen, NL