Quality Engineer
Job Description
An internationally recognized medical device manufacturer is seeking to hire a Quality Engineer to play a pivotal role in supporting product development and lifecycle activities within a highly regulated environment. This position serves as a crucial link between Quality Assurance, Research and Development, and Regulatory Affairs. The successful candidate will be tasked with reviewing, maintaining, and enhancing technical documentation to ensure compliance with the European Medical Device Regulation (EU MDR) as well as overseeing hardware and software medical device projects. You will be expected to apply your expertise to ensure that all design dossiers, risk management files, and validation documents meet stringent quality standards and regulatory requirements.
Key Responsibilities
As a Quality Engineer, your responsibilities will encompass a broad range of tasks aimed at ensuring product quality and compliance.
- Review and assess technical documentation, including design dossiers, design controls, and risk management files.
- Ensure compliance with EU MDR and adhere to ISO standards.
- Evaluate documentation for clarity, consistency, and audit readiness.
- Support the creation and maintenance of quality and technical documentation, including labeling and validation plans.
- Maintain documentation throughout the entire product lifecycle.
- Participate in internal and external audits, responding to inquiries from notified bodies and authorities.
- Coordinate and support change management activities, including Change Board meetings.
- Collaborate closely with R&D, Regulatory Affairs, Production, and Product Management teams.
Required Technical Skills
Soft Skills
Qualifications
- Bachelor's degree in Biomedical Engineering, Life Sciences, or a related field
- Strong knowledge of ISO 13485 and EU MDR
- Experience with additional medical device regulations is a plus
Language Requirements
Programming Languages:
ISO 13485, EU MDR, ISO 14971, IEC 62366, IEC 62304, ISO 10993
Spoken Languages:
English, German
Benefits & Perks
- ✓ Competitive salary
- ✓ Health and wellness programs
- ✓ Professional development opportunities
- ✓ Flexible working hours
- ✓ Work-life balance initiatives
Working Conditions
Full Time
Company Culture
The company fosters a collaborative and innovative environment where employees are encouraged to contribute ideas and drive quality improvements. There is a strong emphasis on continuous learning and professional growth, along with a commitment to regulatory excellence and patient safety.
Salary Range
Project Types: Not Available
Career Growth: Career progression into senior quality roles, Potential to lead quality assurance teams, Opportunities to engage in cross-functional projects