Quality Assurance Officer
Factory is a full service Contract Research Organization (CRO). We are global leader specialized in medical device trials. Our focus lies in the complete management of clinical studies for medical devices, IVDs, biologicals, and drug-device combinations.
Due to increasing growth of the company and expansion of the Quality Assurance Department, Factory CRO is currently looking for a Quality Assurance Officer (1.0 fte) for the office in Bilthoven. In this position, you will work together with and report to the Quality Assurance Manager. You will support all activities to maintain and ensure compliancy to Factory CROs Quality Management System (ISO9001 and ISO13485 certified).
- Support review, approval, distribution and maintenance of Standard Operating Procedures (SOPs)
- Maintain quality control of documents and ensure correct and timely implementation of Change Requests and Change Control forms
- Ensure timely release of Quality Management System (QMS) documents, filing and maintenance of all controlled documents and quality documentation and ensure files are accurate and easily retrievable
- Draft Training Plans and Training Records and collect, file and track training of employees and subcontractors
- Assist QA Manager/Director in preparation and follow up of Management Review
- Support in preparation, performance and follow up of audits (Sponsor, internal audits and DEKRA audits)
- Handle administration and follow up of CAPAs, complaints and nonconformities
- Coordinate critical supplier and subcontractor selection and evaluation process
- Collect and track KPIs
- Support Quality Improvement Projects
- Provide general administrative support to the QA Director and QA Manager
- Bachelor/Master degree in (para-)medical / Life Sciences
- Experience with Quality Systems (e.g. ISO9001, ISO13485) is preferred
- Knowledge of quality standards and requirements for medical devices
- Knowledge of ISO14155/GCP is preferred
- Proficiency in MS Office
- Fluency in written and spoken English
Skills & Characteristics
- Accurate, eye for detail
- Good planning and prioritizing skills
- Excellent interpersonal skills and a strong team mentality
- Independent worker, pro-active attitude
- Good reporting and communication skills
- Problem-solving skills
Are you interested? Please contact us at firstname.lastname@example.org. We are looking forward to receiving your motivation and CV.
Acquisition regarding this vacancy is not appreciated.