QA Manager

The QA manager will regularly manage aspects of QMS, identify potential process improvements, and act accordingly.

QA manager will support development projects and be part of project implementation at OEM.

The QA manager will work closely with OEM in regard to process improvements and ongoing quality activities.

The QA manager will work closely with operations, service, marketing and development to insure fluent and controlled processes.

The QA Manager will be responsible for the overall quality management system, implementation of regulatory standards and MDR

EXPERIENCE/SKILL REQUIREMENTS:

• At least 5 years experience in QA in a medical device company and/or other regulated industry.

• At least 5 year of managerial experience

• Familiar with medical quality standards and processes.

• A well-organized person.

• Ability to lead root cause analysis activity and to engage other members to perform tasks.

• Cross-functional communicator

• Self-accountable person

• Experience in product life management cycle (design process)

OTHER REQUIREMENTS

• A highly reliable person

• Ability to work under pressure and prioritize tasks.

• Able to operate effectively in team with global members and with OEM.

• Experience with QA in a small and growing organization.

• Proficient in written and verbal communication in English

EDUCATIONAL REQUIREMENTS:

• Technical background, ability to read and understand drawings and design specifications.

• Bachelor degree

• Certified auditor – advantage

ORGANIZATIONAL RELATIONSHIPS:

• Reporting to: Quality/Regulatory VP