Quality Engineer (m/f/d)

Straumann Group; Basel; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Straumann Group in Basel is seeking a Quality Engineer to ensure quality, compliance, and continuous improvement across products and processes throughout their lifecycle. The role collaborates with R&D, Procurement, Manufacturing, and Quality teams globally, with occasional travel to sites and suppliers.

Based in Basel, you will help identify risks, support product innovations, and ensure compliance with relevant standards and regulatory requirements.

Qualifikationen

• Degree in Engineering, Life Sciences, Natural Sciences, or related technical discipline.
• Experience in engineering or quality-related roles, ideally in medical devices.
• Knowledge of GD&T, ISO 8015, and regulatory standards (ISO 13485, EU MDR, FDA).

Aufgaben

• Shape product quality through design changes, NPI, PLM, and site transfers.
• Identify, assess, and mitigate product and process risks across realization.
• Support validation activities and maintain FMEAs and validation master plans.
• Lead or support CAPAs, deviations, and change control with root-cause analysis.

Kenntnisse

Quality engineering

Risk assessment

GD&T knowledge

8D / DMAIC / PDCA

Ausbildung

Engineering degree in a technical discipline

Tools

3D CAD software

Technical product documentation

Jobbeschreibung

Are you ready to unlock your potential? At Straumann Group we’re on an exciting journey of growth, innovation, and impact - driven by our mission to improve oral health and transform millions of lives worldwide. United by purpose, we bring our best selves to work every day, embracing a high-performance, player-learner culture that inspires collaboration, curiosity, and ambition. Here, you’ll have the opportunity to take charge of your own career, harnessing your skills, passion, and enthusiasm for learning to continually grow and progress. Together, we’re not just shaping brighter smiles, we’re unlocking the potential of people everywhere, including our own.

Are you passionate about combining engineering expertise with quality excellence to make a meaningful impact on medical devices?

As a Quality Engineer (m/f/d) within our Global Quality Operations team, you will play an important role in ensuring the quality, compliance, and continuous improvement of our products and processes throughout their lifecycle.

Working closely with international colleagues across R&D, Procurement, Manufacturing, and Quality, you will help identify and mitigate risks, support product innovation, and ensure that our solutions meet relevant technical and regulatory requirements.

Based in Basel, you will contribute to global quality initiatives while collaborating with teams across different sites. Occasional travel to manufacturing locations or suppliers may be required.

Your Responsibilities

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

Your Profile

• A degree in Engineering, Life Sciences, Natural Sciences, or a related technical discipline, or equivalent relevant professional experience
• 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

What Makes You a Great Fit

You bring an analytical and structured approach to complex technical challenges, balancing attention to detail with practical, risk-based decision-making. You communicate clearly, collaborate effectively across functions and locations, and value different perspectives when working toward shared goals. You take ownership of your work, approach challenges with curiosity, and look for opportunities to improve processes and outcomes. Most importantly, you bring a willingness to learn, share knowledge, and contribute to a collaborative, high-performance environment where quality and continuous improvement matter.

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