Senior / Staff Quality Engineer (m/f/d) Software Quality

Stryker Group; Freiburg im Breisgau; Hybrid; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

A healthcare technology company in Freiburg is seeking a Senior / Staff Quality Engineer to lead initiatives in quality assurance and regulatory compliance. You will collaborate with cross-functional teams and guide projects through the design control process. A Bachelor’s degree and 2+ years of relevant experience are required, along with proficiency in English. This role offers flexible working hours with partial remote work.

Leistungen

Flexible working hours

Opportunity for permanent position

Qualifikationen

• 2+ years of experience in quality assurance or product development in a regulated industry.
• Proven knowledge of risk management and design control.
• Fluent in English; German skills are a plus.

Aufgaben

• Lead design control activities including risk management and design reviews.
• Collaborate with cross-functional teams to mitigate product risks.
• Provide quality leadership during development of new systems.

Kenntnisse

Quality assurance

Risk management (ISO 14971)

Design control

Communication skills

Analytical skills

Ausbildung

Bachelor’s or Master’s degree in (Bio)Medical Engineering or related field

Jobbeschreibung

Overview

As a Senior / Staff Quality Engineer (m/f/d) working on Stryker’s cutting-edge surgery planning solutions, you’ll play a vital role in shaping the future of pre-operative planning solutions — ultimately improving patient outcomes. Join a company driven by its mission to make healthcare better and known for its culture of integrity, accountability, collaboration, and innovation.

What will you do

• Act as the Quality expert and independent interface between product development, usability engineering, regulatory affairs, test labs, and manufacturing throughout the full product lifecycle — from concept through launch.
• Lead and coordinate design control activities including risk management (ISO 14971), design reviews, and DHF (Design History File) documentation.
• Collaborate with cross-functional teams — R&D, Systems Engineering, Usability, RA, and Software Engineers — to identify, mitigate, and control product risks.
• Guide project teams through the design control process, holding them accountable to ensure quality is built into every phase.
• Support and attend validation and usability studies, including those involving customers, to ensure risk controls are effective and compliant.
• Provide quality leadership during the development of a new system/platform.
• Contribute to continuous improvement initiatives and help ensure compliance with regulatory requirements, including FDA, MDR, ISO 13485, and other relevant standards.

What will you need

Required Qualifications:

• Bachelor’s or Master’s degree in (Bio)Medical Engineering, Electrical/Software Engineering, or a related technical field.
• 2+ years of experience in quality assurance or product development in a regulated industry (preferably medical devices). Based on years of experience the seniority of the role can be adjusted.
• Proven knowledge of risk management (ISO 14971) and design control (21 CFR 820 / MDR).
• Familiarity with software development and the software life cycle process (e.g., IEC 62304).
• Strong communication, coordination, and analytical skills, with a quality-first mindset.
• Fluent in English; comfortable working in an innovative, international environment.

Preferred Qualifications:

• German language skills are a plus.

Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.

Additional information

The position is initially limited to 18 months. Due to the large number of different positions and areas of responsibility, Stryker often offers the options of being taken on in a permanent position.

Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence of 3 days a week on site at our location in Freiburg should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.

The internal job title may differ from the ad title.