In this position, you will lead the Quality Engineering team, drive improvement initiatives, and ensure compliance. You'll collaborate with various teams to enhance efficiency and mentor your team to support their professional growth.
Anforderungen
- •Bachelor's degree in Engineering or Science
- •At least 6 years of quality assurance experience
- •Strong understanding of manufacturing processes
- •Excellent English language skills
- •Strong German language skills
- •Expertise in quality processes like non-conformance management
- •Strong skills in statistical analysis
- •Familiarity with EU MDR and ISO 13485
Deine Aufgaben
- •Lead the Quality Engineering and Technician team.
- •Align priorities and provide daily guidance.
- •Support team development through mentorship.
- •Collaborate with operations and cross-functional teams.
- •Support daily business activities with quality processes.
- •Drive continuous improvement initiatives.
- •Ensure robust risk management and NC/CAPA resolution.
- •Oversee critical QA projects for regulatory compliance.
- •Optimize costs and improve operational efficiency.
- •Focus on process improvements with cost-efficiency.
- •Build robust and sustainable systems.
Original Beschreibung
# Associate Quality Assurance Manager (m/f/d) Medical Devices
**Freiburg, Germany** | **Full time**
Work Flexibility: Hybrid or Onsite
As an **Associate Quality Assurance Manager (m/f/d)** at Stryker, you will lead a team of 12 Quality Engineers and Technicians, playing a key role in driving quality excellence for life-changing medical devices. You’ll oversee daily operations, lead process improvements, and ensure compliance in a highly regulated environment—contributing directly to patient safety and operational efficiency.
**What You Will Do**
* Lead the Quality Engineering and Technician team by setting direction, aligning priorities, providing daily guidance, and supporting team development.
* Collaborate closely with operations and cross-functional teams to support daily business activities and ensure effective quality processes.
* Drive continuous improvement initiatives, ensuring robust risk management, NC/CAPA resolution, and quality planning.
* Oversee critical QA projects to ensure regulatory compliance optimizing costs, and improving operational efficiency.
* Focus on process improvements with a cost-efficiency mindset, building robust, efficient, and sustainable systems.
* Support the growth and development of your team, providing coaching and mentoring to build technical and leadership capabilities.
**What You Will Need**
*Required Qualifications:*
* Bachelor’s or Master’s degree in Engineering, Science, or a related field.
* 0–3 years of experience in managing complex processes, projects, or quality-related initiatives. People leadership experience is a plus, but not required.
* 6+ years of technical experience in quality assurance, manufacturing, production, or a similar field within a highly regulated industry (medical devices, pharma, aerospace, food & beverage).
* Solid understanding of manufacturing processes in medical devices or other high-risk, regulated industries.
* Excellent English and German language skills, enabling seamless collaboration with global and local stakeholders.
*Preferred Qualifications:*
* Expertise in key quality processes, including non-conformance management, continuous improvement, auditing practices, lean tools, and core quality assurance techniques such as PFMEA, risk analysis, and inspection planning.
* Strong skills in statistical analysis and data-driven decision-making.
* Familiarity with EU MDR, ISO 13485, FDA 21 CFR Part 820, and global quality standards is desirable.
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**
Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence of 3-4 days a week on site in Freiburg should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.
Travel Percentage: 10%