QA&RA

Operations QA Manager

Description:

Vectorious Medical Technology seeks talented Quality Assurance Operations Manager to innovate healthcare globally. With successful in-heart microcomputer implants, our breakthroughs have a huge potential to help millions of individuals with heart failure manage their condition effectively, leading to stability, fewer hospitalizations, and extended, fulfilling lives.

If you're passionate about making a difference and have the skills to contribute, apply today for an exciting opportunity!

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.
• Handle supplier quality management, including supplier qualification and evaluation, quality agreements, and conducting supplier quality audit.
• Review and approve manufacturing records (DHR) as part of lot/batch release approval process.
• Review and approve validation protocols and reports.
• 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 for equipment adequacy, calibration, maintenance, and validation 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?:

• 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 in conducting supplier quality audit in Israel and abroad.
• 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.