QA Documentation Specialist

We are looking for a QA Documentation Specialist Within a medical device environment, assist QA Manager in maintenance of the Quality System documents and records.

Document Control and Training Manager is responsible for managing the QA Document Control System and CSW QS Training Program ensuring compliance to quality objectives and regulatory requirements

Key Accountabilities:

Be a key part of a team where you will:

• Implements, maintains and improves the Document Control process and provides support to the QS Training program to ensure compliance with best documentation practices and records control.
• Provides administration aid and troubleshooting for the SAP quality system modules. Provides internal technical support and escalates as appropriate to Werfen IT support.
• Ensure and participates in the validation of the computer software used for the Quality System processes
• Maintains documents and records as required by applicable regulations such that required documentation is retrievable and files are accurate, complete and well organized.
• Ensure that updates of quality system documentation is done as necessary
• Manages the collection and maintenance of QA department metrics
• Typing of procedures , work instructions and other documents relating to Quality.
• Complete Purchase Orders for QARA department
• Maintains standards and regulatory guidelines database.
• Maintain competence matrix for employee training. Update as training is performed and removal of personnel from data base as required. Monitors training effectiveness evaluation and and monitors training compliance for staff.
• Provides support for internal and regulatory audits and inspections as required.

Education: Bachelor's degree or 3-5 years related experience and/or training; or equivalent combination of education and experience.

Experience:

At least 2 years experience in a Document Control related position

Language: Spanish and English

Knowledge and experience working with Quality System standards (ISO 9001, ISO 13485..).

Desirable:

• Experience in Quality System related position preferably within the Healthcare sector
• Experience with Computer Validation is a plus
• Internal auditor qualification for management systems or knowledge of auditing techniques
• Experience working with a eQMS is a plus
• Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement

What we offer:

• A meaningful project that will impact the quality of laboratory software medicine worldwide
• 3 days a week working from home
• Multicultural and friendly team
• Exciting opportunities for professional development.
• Ongoing training
• Social benefits: Canteen, nursery check, English training...
• All the benefits according to the chemical agreement