Quality Engineer (m/f/d)

As a Quality Engineer (m/f/d) at Straumann Group in Switzerland, you will play a pivotal role in ensuring the quality, compliance, and continuous improvement of medical devices and processes. Working within the Global Quality Operations team, you will collaborate with international colleagues across R&D, Procurement, Manufacturing, and Quality to support product innovation and risk mitigation. This position offers the opportunity to contribute to global quality initiatives and drive continuous improvement in a high-performance, player-learner culture.

• Support quality engineering activities related to design changes, new product introductions, product lifecycle management, and manufacturing site transfers.
• Collaborate with global teams to identify, assess, and mitigate product and process risks throughout product realisation.
• Contribute to the introduction of new products and processes using quality tools such as FMEA, SPC, control plans, and measurement system analysis (MSA).
• Review engineering drawings, material specifications, and product documentation against applicable standards and regulatory requirements.
• Coordinate technical assessments with subject matter experts, considering standards compliance and manufacturing feasibility.
• Support validation and risk management activities, including the maintenance of process FMEAs and validation master plans.
• Lead or support nonconformity investigations, CAPAs, deviations, and change control, including root-cause analysis and effectiveness checks.
• Maintain engineering and design standards within the quality management system and contribute to a culture of continuous improvement.

• Relevant experience in engineering or quality-related roles, ideally within the medical device industry.
• Knowledge of engineering drawings, geometric dimensioning and tolerancing, and relevant standards such as ISO 8015, GD&T, and GPS.
• A sound understanding of mechanics, manufacturing processes, materials, and tolerances.
• Experience with 3D CAD software and technical product documentation.
• Familiarity with medical device quality and regulatory requirements, including ISO 13485, EU MDR, and applicable FDA requirements.
• Experience with quality tools and structured problem-solving methodologies such as 8D, DMAIC, or PDCA.
• Additional training in quality management, auditing, statistics, or risk management.
• Strong analytical and structured approach to complex technical challenges.
• Excellent communication and collaboration skills across functions and locations.
• A degree in Engineering, Life Sciences, Natural Sciences, or a related technical discipline, or equivalent relevant professional experience.

Straumann Group operates in Switzerland and focuses on medical devices, offering opportunities to contribute to global quality initiatives in a high-performance environment.

You will work within the Global Quality Operations team and collaborate with international colleagues across R&D, Procurement, Manufacturing, and Quality.