Quality Engineer - Rümlang, Schweiz - greenteg AG

Beschreibung

greenteg AG develops, produces, and markets cutting-edge thermal measurement solutions for life sciences and IoT sectors. Operating globally from our headquarters in Zurich-Rümlang, our dynamic and international team serves a diverse clientele.

We are seeking a Quality Engineer specializing in Quality Management Systems (QMS) with responsibilities in developing design and development documentation for both software components and hardware (sensors), ensuring alignment with international standards, and optimizing production quality. The candidate will play a critical role in maintaining compliance with ISO 9001, ISO 13485, IEC 62304 and other applicable standards, while ensuring quality control in product development and heat flux sensor production.

Department: QARA - Quality Assurance and Regulatory Affairs.

Work permit: The candidate should have a valid permit to work in Switzerland or be a citizen of an EU/EFTA country.

Start date: July 1, 2024 or earlier.

Tasks

Quality Management System

• Ensuring compliance with regulatory and corporate requirements, assuring product quality and maintaining an operable quality system that is effective and efficient.
• Collecting data and preparing KPIs for reporting to relevant stakeholders (e.g. Management Review Meeting, Data Reporting).
• Performing document control and processing change requests in our electronic QMS.
• Supporting internal and external audits/inspections.

Design and Development Documentation and Quality Control

• Developing and ensuring compliant design history files for SW and HW products.
• Controlling design changes.
• Facilitating the requirements engineering process.

Manufacturing Quality Control

• Supporting Manufacturing with business process mapping (BPM).
• Collecting and identifying improvement potential for manufacturing processes, implementing this in close collaboration with the COO and the project leader.
• Facilitating training programs for production staff on quality control standards and best practices.

Cross-functional Collaboration:

• Working closely with engineering, production and integration teams to ensure seamless integration of quality system requirements into design and development and manufacturing.
• BPM: Mapping business processes of the organization and facilitating the development of responsibility assignment matrices.
• Supporting process owners in continual improvement of their processes and liaising with them on interface management topics.

Requirements

• Technical education background, preferably in engineering or a related field, is preferable.
• Additional qualifications in Quality Management Systems (QSR, ISO 19011, ISO 9001/ISO 13485, IEC 62304, Six Sigma, Lean Manufacturing) are preferable.
• At least 2 years of experience in quality engineering within the medical device or sensor manufacturing industries are required.
• Experience with quality control in sensor manufacturing and software development or similar industries is preferable.
• Proficiency in English (C1) is required, proficiency in German (C1) is beneficial, enabling effective communication within our international team and with external stakeholders.
• Effective communication skills (intra- and cross-departmental) and ability to successfully facilitate between stakeholders of different departments are required.
• Strong problem-solving skills including issue identification, identification of potential solutions, implementing solutions, and evaluating effectiveness are beneficial.
• Hands-on, resilient personality, with flexibility, dedication and pragmatism is required.
• Analytical and structured working style with strong attention to detail is required.
• Strong computer skills, including experience with quality control, measurement and testing techniques are preferable.

Benefits

What we offer:

• A stimulating role in high-tech manufacturing, involving diverse technologies.
• Collaborative participation in enhancing company processes.
• A vibrant startup culture within a growth-driven company.
• An energetic, young, and international team.
• 25 paid vacation days (at a 100% workload).
• Option for remote work (one home office day per full work week at a 100% workload).