Senior Quality Assurance Engineer

We are growing fast and looking to add to our team a talented Senior Quality Assurance Engineer.

The chosen candidate will lead and execute a variety of QA activities

This is an opportunity to play a key role in a medical devices company aiming at improving patients’ quality of life globally.

Responsibilities:

R&D Support:

Writing and development of Design Control documentation

Performing risk analysis

Drafting V&V protocols

Leading Engineering Change Orders

Applying relevant standards and regulations

Support of outsourced manufacturing (CMOs):

Suppliers’ audits, qualifications, Quality Agreements

Process validations and re-validations, process control

Incoming Inspection, Calibration

NCR, CAPA, Change Control, Analysis of Data etc.

Lot Release

QMS Support:

Document Control

Management Review

Vigilance Reporting, Complaints Handling

Post-marketing Surveillance

Internal Audit

Training and Mentoring of Quality Assurance Team

Qualifications:

Proven experience of min. 5 years in medical devices quality assurance – a must

Knowledge of ISO 13485:2016, EU MDR, FDA QSR, ISO 14971:2019 – a must

Bachelor's degree – a must. Degree in life science / exact sciences / engineering – an advantage.

Proficiency in English - speaking, writing, and reading - a must

Experience in statistical analysis - a significant advantage

Experience in regulatory submissions to the FDA, Notified Bodies - an advantage

Knowledge of Minitab SW – an advantage

Reporting to QA/RA Director

Location: center, Hybrid