Coat-X SA is an innovative company providing unique coating services and equipment solutions. The company is looking for a QA Manager whose main missions will be to maintain and improve the existing Quality Management System in compliance with ISO13485 and lead the medical customers qualification projects within the company.

Responsibilities

• Manage, review, improve and approve procedures, templates and work instructions assuring compliance to ISO 13485 and ISO 14971.
• Define and drive the internal audit plan.
• Lead and assist during external audits (certification bodies and customers).
• Organise and lead management reviews, act as management representative.
• Perform the standards regulatory surveillance.
• Define and execute process validations with the Engineering Manager.
• Review documentation and release of production batches, including non-conformities.
• Owns internal CAPA process and CAPA reports.
• Manage supplier classification and validation.
• Oversight and management of change requests and documents control approval flow.
• Ensures proper monitoring of equipment calibrations and clean room qualification (ISO5).
• Definition and execution of customer project process validation.
• Medical customers project lead or co-lead assuring customer requirements are met, including Quality Agreement, Process validation and Purchase Specifications.