QA Engineer / QA Specialist
Vectorious has developed the world’s first in-heart microcomputer and is on a mission to transform heart failure treatment. As part of our first in-human clinical study, we have successfully implanted our sensory device in patients across Europe and Israel, while demonstrating a huge potential in helping millions of people living with heart failure to take control and manage their disease. As an increasingly growing company we’ve been accepted to FDA’s prestige Breakthrough Device Designation program.
We are looking for an experienced Quality Assurance Engineer / Specialist to join our QA group and to support our meaningful growth.
What will you do?
- Provide quality support and guidance to various to company’s departments (Operations, R&D, Clinical, Support) under quality system requirements.
- Taking part in managing Quality System processes in accordance with ISO 13485, FDA QSR 21CFR820 and other applicable regulatory requirements (such as: CAPA, ECO, MRB/Non-conformities, Training, Calibrations, Document Control, Customer Complaints, etc.).
- Identify the opportunities for continuous improvement of the Quality System, and taking part in improvement of the Quality System, QA Procedures updates, implementation, and guidance to company employees.
- Assist in reviewing manufacturing documents (DMR documents, work instructions, specifications, DHR, Lot Release), and review engineering/design change reports (ECOs) and provide inputs related to quality issues.
- Provide support to manufacturing for QA/QC related issues, including DHR review and Lot Release, working and communicating with suppliers/ subcontractors in Israel and abroad.
- Maintaining the DHF and assist in reviewing R&D documents (DHF documents, Verification and Validation, Risk Analysis, Design Reviews, etc.) and provide inputs related to quality issues.
What do you need to bring with you?
- Experience working in medical device company- must! (unfortunately candidates without this experience are not relevant)
- Bachelor’s degree in Electrical/ Mechanical/ Biomedical/ Biotecgnology Engineering or other Scientific degree (Chemistry, Biology), or equivalent
- 3+ years of experience in Quality Assurance at Medical Device companies, producing sterile, biocompatible, electromechanical products which include software (active implants companies – an advantage).
- Familiarity with international quality regulations – ISO 13485, ISO 14971, US 21 CFR 820 etc.
- Ability to partner with Operation and R&D departments and collaborate with various departments within the organization.
- Familiarity and experience in design control processes and DHF documents (including: Requirements specification documents, V&V, design reviews, Risk Analysis)
- Experience in providing QA/QC support and guidance to operations (supply chain and manufacturing), including: purchasing, warehouse, incoming, in-process and final inspections. (Manufacturing in clean room – an advantage)
- Experience in working and communicating with suppliers/ subcontractors in Israel and abroad, on production quality issues. (Suppliers audit experience – an advantage)
- Experience in writing and reviewing manufacturing procedures/ work instructions/ forms, DHR, route cards, inspection reports, related to manufacturing processes.
- Experience in writing, reviewing and handling of: engineering/ design changes (ECO), non-conformities (NCR/MRB), CAPA, customer complaints, equipment calibration reports.
- Technical writing skills.
- Languages: English – excellent level
- Experience in implementing and guide quality standards in day-to-day activity.
- An ability to successfully communicate and educate QMS regulations, policies and strategies to employees at all levels of the organization.