Менеджер систем якості (ISO 13485)

Location: Харьковское Шоссе

Start date: ASAP

Position: Full-time

Holiday: 4 weeks per year

About us

We are an American-Ukrainian joint venture company. We design, develop and manufacture medical devices. We operate to ISO 13485:2016 medical device quality standards. We wish to recruit a Quality Manager to support the growth of our Manufacturing business. The individual will report to the CEO and will have access to support from an external Quality Consultant.

Main responsibilities: Implement, disseminate and maintain QMS documentation and document control; Implement effective QMS processes in conjunction with operating staff; Maintain QMS processes such as audits (internal and external), supplier qualification, change control, non-conforming product and corrective and preventive action systems; Compile, assess and monitor ongoing quality tracking metrics to help drive efficiency and continual improvement; Act as the management representative for ISO 13485:2016; Schedule and carry out routine quality control tests; Support internal validation activities; Compile Quality documents including Certificates of Analysis, technical files and batch records; Assist line managers in implementing Health and Safety systems and procedures; Assist in the investigation of internal and external non-conformances;

Experience, Skills and Attributes

Educated to BSc or equivalent in Science or Engineering;

At least 5 years' experience working in a quality control environment, including design and validation of quality control assays, ideally in a medical related industry;

Experience with QMS ISO13485, EU MDD 93/42/EEC and Risk Management to EN ISO 14971;

Excellent communication and interpersonal skills, in particular, the communication of QA information to non-QA audiences;

Knowledge of Health and Safety in the workplace is preferred;

Proficient with standard software such as MS Office;

Enthusiasm for quality assurance!