ISO13485 Technical Documentation Reviewer

ISO13485 Technical Documentation Reviewer

KEY WORDS:Technical documentation, Validation, Validatie, Technical documentation, cGMP, GAMP, ISO13485, ISO9001, QMS, interim, freelance, tijdelijk, contractor, pharma, Medical Devices, Lean six sigma, QA, kwaliteit, kalibratie, calibration, farmaceutica, healthcare, food, installations, cosmetics, sciences, R&D, Chemical, HSE, Master, PhD, Regulatory Projects, Blackbelt, Greenbelt, process validation, CMO, CRO, project, engineer, inginieur, technoloog, FDA, audits

Location:Zuid-Holland
Type: Contract/freelance
Duration:5/6 months
Start date:ASAP, urgent position
Days per week:Minimum of 3 days per week

As part of a large internal technical documentation project, Amoria Bond is urgently looking for a Technical Documentation Reviewer with thorough experience within the Medical Devices sector.

The technical documentation/validation engineer is responsible for:

*Evaluate all current technical documentation of over 25 product groups
*Write and update service as well as product related documentation
*Act as main point of reference for quality related questions for the Documentation project
*Provide input to the QA manager on technical documentation that need to be authorised
*Coordinate with the QA officers and managers to promote best practices within the office

Profile requirements

*Provable experience in Technical Documentation reviews/QA/Validation
*Candidates must have experience within the Medical Devices field
*Thorough knowledge on cGMP regulations, ISO13485 and FDA, 93/42/EEC
*Experience with process validation (IQ,OQ,PQ)
*Risk management experience
*Great eye for detail and a strong affinity for Quality Assurance
*A BSc+ degree in relevant area
*Strong communication skills in Dutch and English

The Technical Document Reviewer will report into the Project Manager of the Documentation project and the QA/RA Director.

Interested in this position? Please send your profile to (see below) and I will get in touch with you on a short time notice.

Disclaimer: Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.