Quality Engineer (m/w/d) Complaint Handling/Post Market Surveillance - zunächst auf 24 Monate befristet
Stryker · Freiburg, Germany
Work Flexibility: Hybrid or Onsite
(Senior) Quality Engineer, Post-Market Surveillance (m/f/d)
As a (Senior) Quality Engineer (m/f/d) in Post-Market Surveillance, you will be part of our Post-Market Surveillance team at our Freiburg site. Your primary responsibility will be to investigate complaints from the field, including complaints related to patient-specific products within the Craniomaxillofacial business.
What We Offer
- Conduct structured investigations of reported field cases, including cases involving patient-specific products. You will investigate both technical and clinical aspects and collaborate with subject-matter experts from the relevant functions.
- Discuss and evaluate individual cases based on the investigation results, risk assessments, and manufacturing data. In this role, you will work closely with partners from Quality, R&D, Manufacturing, Regulatory Affairs, and Clinical Affairs.
- Independently analyze data, including identified failure modes and root causes, to detect critical developments and emerging trends.
- Actively contribute to operational, cross-functional projects aimed at achieving sustainable product improvements. You will also serve as the key point of contact for the field performance of your assigned product portfolio.
What You Bring
Required Qualifications
- A completed technical degree in mechanical engineering, medical engineering, materials science, or a comparable qualification.
- Initial practical experience in a quality function or a quality-related role within a regulated industry, such as medical technology, pharmaceuticals, or automotive, is an advantage. This may include internships or working-student experience. Depending on the candidate’s level of experience, the position may be offered at a more senior level.
- Strong analytical thinking and problem-solving skills, with experience in root cause analysis and trend identification.
- A collaborative mindset and strong communication skills, with an interest in working across functions.
- Very good written and spoken German and English skills.
Preferred Qualifications
- Experience with ISO 13485 and Post-Market Surveillance requirements under Regulation (EU) 2017/745, also known as the EU Medical Device Regulation.
Germany Pay Ranges:
- Freiburg/Stetten 35Std: €3.753 - €6.225 EUR Monthly
- Freiburg/Stetten 39Std: €4.182 - €6.937 EUR Monthly
At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.
If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.
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