Job Summary
The Manufacturing Engineer is responsible for supporting and improving manufacturing processes to ensure product quality, compliance, and operational efficiency. This role will lead non-conformance (NC) investigations, ensure accurate documentation, and manage process validation activities (IQ/OQ/PQ). Additionally, the Manufacturing Engineer will drive process optimization initiatives, update work instructions, and collaborate cross-functionally to maintain compliance with internal procedures and regulatory requirements.
Essential Duties And Responsibilities
* Lead and document investigations of non-conformances (NCs), ensuring timely root cause analysis, corrective and preventive actions (CAPA), and compliance with quality standards.
* Prepare, review, and maintain documentation related to NCs, validations, and process improvements in line with regulatory and company requirements.
* Plan, execute, and document process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
* Analyze manufacturing processes and identify opportunities for optimization to improve quality, cost efficiency, and throughput.
Job Qualifications
* Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.
* Proven experience in manufacturing engineering, process validation, or quality engineering (experience in regulated industries such as medical devices, pharmaceuticals, or aerospace preferred).
* Strong knowledge of validation requirements (IQ/OQ/PQ) and NC/CAPA processes.
* Familiarity with regulatory and quality standards (e.g., ISO 13485, FDA 21 CFR Part 820, GMP).
* Excellent problem-solving, analytical, and documentation skills.
Knowledge Requirements
* Professional proficiency in English and German, both written and spoken.
* Attention to detail and strong organizational skills.
* Ability to manage multiple tasks and priorities in a fast-paced environment.
* Continuous improvement mindset and proactive approach to problem-solving.
* Commitment to quality and compliance.
Other Details
* Seniority level: Entry level
* Employment type: Full-time
* Job function: Management and Manufacturing
* Industries: Appliances, Electrical, and Electronics Manufacturing
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