Senior Quality Assurance Engineer

DALI Medical Devices, a company founded in 2003, develops, manufactures and sells novel injectable drug delivery devices to global pharma and medical device companies.

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, targeted on leveraging DALI’s QA abilities.

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

(Reporting to QA/RA Director)

Responsibilities

This role will support DALI’s development and manufacturing projects in the following areas:

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

·      Technical orientation – an advantage

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

·      Knowledge of Minitab SW – an advantage

Personal and Interpersonal capabilities:

·      Excellent team and interfaces player

·      Able to move things forward

·      Ability to work under pressure and tight due dates

·      Training and coaching of fellow employees

·      Attentive to details and critical minded

·      Striving for excellence

The role will be performed at DALI’S offices, located in Yavne, in the vicinity of Yavne West train station and in the manufacturing plants of our subcontractors – travel is required.

At DALI, we support hybrid work.