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Stryker

Manufactures orthopedic and surgical medical devices

Quality Engineer - Complaint Handling/Post Market Surveillance

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeFreiburg im Breisgau, Germany€3.8k - €6.9k /mo

About the Job

Requirements

  • A completed technical degree in mechanical engineering, medical engineering, materials science, or a comparable qualification is required.
  • Initial practical experience in a quality function or quality-related role within a regulated industry, such as medical technology, pharmaceuticals, or automotive, is advantageous; this may include internship or working-student experience. The position may be offered at a more senior level depending on experience.
  • Strong analytical thinking and problem-solving skills are required, with experience in root cause analysis and trend identification.
  • A collaborative mindset and strong communication skills, with an interest in working across functions, are required.
  • Very good written and spoken German and English skills are required.

Responsibilities

  • Conduct structured investigations of reported field cases, including cases involving patient-specific products, investigating technical and clinical aspects and collaborating with subject-matter experts from relevant functions.
  • Discuss and evaluate individual cases based on investigation results, risk assessments, and manufacturing data, working closely with Quality, R&D, Manufacturing, Regulatory Affairs, and Clinical Affairs partners.
  • Independently analyze data, including identified failure modes and root causes, to detect critical developments and emerging trends.
  • Contribute to operational, cross-functional projects aimed at sustainable product improvements and serve as the key point of contact for the field performance of the assigned product portfolio.

Desired Qualifications

  • Experience with ISO 13485 and Post-Market Surveillance requirements under Regulation (EU) 2017/745, the EU Medical Device Regulation, is preferred.

About the Company

Stryker

Manufactures orthopedic and surgical medical devices

Stryker makes medical devices for hospitals, surgical centers and emergency responders, spanning joint implants, surgical instruments and patient transport equipment. Its Mako platform assists surgeons with joint replacement, while its neurotechnology products support brain and spine procedures and stroke treatment. Clinicians use its equipment during surgery and emergency care, and the company earns money by selling implants, disposable products and capital equipment through direct sales teams and distributors. The business also supplies training and technical support for healthcare providers using its devices. Stryker was founded in 1941 and is headquartered in Portage, Michigan.

Company size
10,001+
Company stage
IPO
Headquarters
Portage, MI
Founded
1941

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