Careers at Medasense
Quality Assurance Manager (Medical Device)
About The Position
We are looking for a talented and passionate Quality Assurance manager to lead quality at both the product and system level for an innovative patient monitoring device combining state of the art algorithms, software, electronics and hardware. The QA Manager will be responsible for the building and execution of work processes that ensure that all external and internal requirements are met before and after our product reaches our customers. In addition to exceptional leadership, communication and analytical skills, you must have a “roll-up your sleeves” attitude and a deep understanding of global regulatory requirements in the medical device world.
Duties and Responsibilities
- Oversight and performance of all routine QA activities ( CAPA, complaint handling & vigilance, document control, risk management, failure investigations, purchasing controls etc.) ensuring compliance with regulatory and company procedure requirements.
- audit preparation and participation in internal and external audits
- leading quality initiatives with operations to improve manufacturing processes and product quality.
- preparation of mgmt. reviews of quality system
- Compilation and maintenance of Technical Files / Design History Files.
- Overseeing design controls from user needs to serial production
Working hours: Full-time job. The position requires travelling from time to time to suppliers in the north of Israel and abroad.
Report to: VP Clinical, Regulatory and Quality.
Interfaces with: Operations, Hardware, SW, marketing Clinical & Regulation.
- BSc in engineering or Certified Quality Engineer (CQE)
- 3 years of experience as a QA Manager at a Medical Device company
- Familiar with quality system standards ISO 13485,, MDSAP, MDD , 21CFR 820, ISO 14971. Knowledge of MDR an advantage
- Familiar with device standards such as IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993 and usability standards
- Experience in leading external and internal audits
- Certified auditor – an advantage
- Familiar with Agile or other document control systems- an advantage
- Excellent Hebrew and English.
- Strong attention to detail and accuracy
- Well organized with an understanding of priorities and changing demands
- Highly motivated, team player, passionate with independent learning and working abilities