Oversees manufacturing processes to ensure compliance to quality requirements and specifications.
Routinely monitors, evaluates and reports manufacturing quality performance.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Reviews and analyses production failures and drives continual improvement.
Monitors Non-Conformance (NC) and corrective actions (CAPA) execution.
Ensures that corrective measures meet acceptable standards and that documentation is compliant with requirements.
Lead relevant Material Review Boards (MRB).
Oversees and supports equipment & process validation – documentation, execution and recording.
Reviews and approves production files and procedures. Assures that quality requirements are addressed.
Executes internal audits.
- B.Sc. in Mechanical, Electronics, Materials, Industrial, Biomedical Engineering or other relevant field
- Quality Engineer with orientation to manufacturing quality.
- At least 5 years in Quality Engineering, preferred previous experience in R&D and manufacturing environment.
- Excellent Hebrew & English as a working language – reading, writing and speech.
- Good knowledge of ISO standards. Knowledge with ISO13485 and FDA requirements preferred.
- Proven experience with Quality tools, such as: FMEA, Lean manufacturing, Kaizen, SPC, PPAP, DMAIC. Six-Sigma preferred.
- Proven experience with Validation processes: IQ, OQ, PQ, MSA, GR&R.
- Proficient with Office applications
- Experience as user in ERP applications (e.g. Priority, SAP) and PDM systems (e.g. Agile).
- Fast learner capable of self-management
- Team player, comfortable in a matrix environment
- Needing strong interpersonal communications and ability to work with a cross-functional team.
- Certified Quality Engineer (CQE) – Preferred
- Background in Medical Device manufacturing.
- Certified quality auditor (CQA) or lead auditor