Senior Quality Engineer (m/f/d)

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