Beschreibung
For our customer within the medical sector, we are searching to fill for the area Tuttlingen the projectQuality System Engineer (f/m) on freelance basis
This is a project on freelance basis and the Start is planned for September, duration is planned for 3 months.
Tasks:
- Ensures consistent & correct execution of QS procedures at the site to maintain the quality and compliance of processes and records for NC, CAPA, IA Observations, Product - Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR
- Review site CAPAs, NCs, IA Observations, Site Complaint Manufacturing Investigations, QPR & QSMR documentation
- Provide guidance on requirements
- Interact with & influence cross-functional and cross-business teams to drive results
Skills required:
- Background in Engineering is preferred, or associated relevant Scientific / Technical / Quality discipline
- Experience in Medical Device or Pharmaceutical environment
- Experience in working in a manufacturing / operations environment is preferred
- Knowledge of ISO 9001 & QSR regulations
- Experience in Quality Auditing & notified body inspections is preferred
- Experience with root cause investigation, change management, risk management and technical writing is required
- Experience in Quality Systems process development, support, integration or enhancement is preferred
- Advanced use of computer and software applications is required
- Strong business acumen, interpersonal skills relating to teams with diverse cultures and business practices
- Strong verbal and written communications skills for multi-level stakeholders
- Strategic & tactical execution abilities, including strong organization skills
- Ability to analyze, graph, and present data in a way that facilitates & drives decision making
Please don't hesitate to contact us in case you have further questions: Tel:
Sarah Simon
Kelly Services Hamburg
T:
sarah.simon[at]kellyservices.de