Beschreibung
Dear Sir or Madam,I am currently looking for a Senior Quality Engineer (m/f/d) for my customer in the Medical Devices sector.
Startdate: asap
Enddate: 18 months, extension possible
Location: Leipzig
Workload: Fulltime
Contract type: temporary
Key Responsibilities:
- Manage and improve the quality management system based on ISO 13485:2016
- Plan, conduct and report internal and external audits
- Prepare and take part in regulatory inspections
- Ensure auditing and manufacturing documentation is kept up to date by the responsible departments
- Manage periodic and ongoing review of standards, documents and procedures
- Review the batch documentation of the medical devices
- Problem-solving for ongoing process improvements
- Manage Nonconformances and perform and document root cause investigations
- Issue and manage Corrective and Preventive Actions (CAPAs)
- Perform trainings on the quality management system
- Coordinate the change control procedure within the company
- Support management review
- Keep the Technical Documentation up to date
- Support validation including computer system validation and data integrity topics
- Coordinate and serve as the contact with contract organizations and service providers related to quality aspects
- Ensure effective Risk Management
- Manage supplier qualification and evaluation
- Responsible for complaint handling and post market surveillance
Requirements:
- Completed bachelor or master's degree (preferred) in biomedical engineering or equivalent degree in technical/technological/bioscience field.
- Minimum two years of experience in quality management in a medical device company
- Demonstrated experience in quality oversight and management of products through the product lifecycle
- Knowledge of the ISO 13485:2016 standard and EU MDR (Medical Device Regulation)
- Internal auditor qualification
- Ability to take over the function as quality management representative and deputy person responsible for regulatory compliance according article 15 MDR
- Affinity to standard IT systems like MS office
- Proficient in German and English, both written and spoken
- Self-starter and team player
Perfect match?! Send your documents (resume, certificates, references), availability and salary expectation by email.
If it's not suitable for you, reach out to your network - we would be thrilled about a recommendation!
Best regards