Job Title: V&V Manager
Location: Caesarea, Israel
Reports to: Director of R&D
Job Description: The V&V Manager will lead a team of Verification & Validation Engineers and drive adoption of Verification & Validation methodologies to improve product outcomes.
Note: The following meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
Key Responsibilities & Authorities:
- Responsible for all V&V activity for System, Sub-system, Robot and Tools.
- Manage the definition, integration, execution and report of verification activities against requirements.
- Manage the definition, integration, execution and report of validation activities against use needs.
- Professional owner of V&V best practices, methodology and a subject matter expert for related development and test standards (e.g. Statistical techniques, Sterilization and reprocessing)
- Represents Mazor V&V activity in internal and external audits
- Responsible to reproduce failure modes to facilitate with root cause investigations of customer complaints or defects
- Responsible for employee’s development plan, including management by objectives, on the job and annual feedback process
- Overall responsibility for training and qualification of team members
- Compliance to Medical Device industry requirements
A degree in Bio-science, Biotech or related background
- Minimum of 3 years in medical device industry V&V with a strong emphasis on quality assurance, problem solving, along with written and verbal skills.
- Proven experience with Verification and Validation of multi-disciplinary systems.
- Experience with Medical Device Quality Systems and related requirements, including ISO 13485:2003 and FDA CFR21 Part 820.
- Managerial experience.
Job Specific Skills (Languages, SW, systems, etc.'):
Strong technical orientation and understanding of multi-disciplinary systems
English - full control, read and write
Software – MS Office in high level, Qpack – an advantage
Other Requirements for the role (% of travel, etc.):
Ability to work in a team minded approach to achieve individual and company success. Able to confidently deal with ambiguous issues and provide input towards suitable actions. Self-learning abilities. Some travel abroad for joint development/testing activities and laboratories might be required.
Internal: Requires interface with System Engineering, Applications, Robotics, Engineering, quality, regulatory, product, technical communications, end users, technical support, production, and suppliers.
External: Suppliers, Manufacturers