Manufacturing QA Engineer
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 Manufacturing Quality Assurance Engineer to join our QA group and to support our meaningful growth.
What will you do?
- Provide quality support and guidance to Operations and Manufacturing teams, under quality system requirements.
- Review DMR and manufacturing documents, work instructions and procedures, engineering/design change reports (ECOs) and provide inputs related to QA/QC.
- Review manufacturing records (DHR) as part of lot/batch release approval process.
- Identify the opportunities for continuous improvement of the Quality System, specifically manufacturing processes.
- Provide guidance and decisions on manufacturing activities to ensure compliance with internal procedure and regulatory requirements.
- Take active role in planning process validation activities, and in production risk management (PFMEA).
- Establish process of cascading critical characteristics (CTQ) into critical control points (CCPs), manufacturing process specifications and defining KPIs for these characteristics
- Prepare supply chain related inputs for CRBs, Quality Management Reviews, etc.
- Working and communicating with suppliers/ subcontractors in Israel and abroad, on production quality issues.
- Responsibility on equipment calibration and maintenance definitions and activities.
- Handling non-conformities detected in production, and participate in MRB committee.
- Identify opportunities to proactively assure compliance to international quality regulations e.g., ISO 13485, ISO14971, US 21 CFR 820 etc.
- Define and implement process control & monitoring over Manufacturing.
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 Engineering (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 Manufacturing and Operation departments and collaborate with various departments within the organization.
- Significant experience in providing QA/QC support and guidance to manufacturing, including 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 production risk management and process validation.
- Experience in writing and reviewing manufacturing procedures/ work instructions/ forms related to manufacturing processes.
- Experience in batch/lot release, including reviewing manufacturing records, route cards, inspection reports, sterilization records (DHR).
- Experience in writing and reviewing engineering/design changes (ECO).
- Experience handling non-conformities (NCR/MRB) in production.
- Experience in reviewing and approving equipment calibration reports.
- Technical writing skills.
- Languages: English – excellent level
- An ability to successfully communicate and educate QMS regulations, policies and strategies to employees at all levels of the organization.