We are looking for a QA Documentation Specialist within a medical device environment to assist the QA Manager in the maintenance of the Quality System documents and records.
The Document Control and Training Manager is responsible for managing the QA Document Control System and CSW QS Training Program, ensuring compliance with quality objectives and regulatory requirements.
Key Accountabilities:
Be a key part of a team where you will:
Implement, maintain, and improve the Document Control process and provide support to the QS Training program to ensure compliance with best documentation practices and records control.
Provide administration aid and troubleshooting for the SAP quality system modules. Provide internal technical support and escalate as appropriate to Werfen IT support.
Ensure and participate in the validation of the computer software used for the Quality System processes.
Maintain 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 are done as necessary.
Manage the collection and maintenance of QA department metrics.
Type procedures, work instructions, and other documents relating to Quality.
Complete Purchase Orders for the QARA department.
Maintain standards and regulatory guidelines database.
Maintain the competence matrix for employee training. Update as training is performed and remove personnel from the database as required. Monitor training effectiveness evaluation and monitor training compliance for staff.
Provide 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: Knowledge and experience working with Quality System standards (ISO 9001, ISO 13485).
Experience in a 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 an 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.
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