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Open Positions at ENvizion Ltd. (Israel)
Reports to: to: VP QA/RA
Job Description
As the Quality Engineering Manager, you will work closely with multiple teams working on and being responsible for the development, implementation, and maintenance of the ENvizion’s Quality Management System and related programs. The incumbent in this position must have detailed working knowledge of common QMS models including ISO 13485 and the FDA’s Quality System Regulation. Demonstrated leadership skills and ability to make risk-based decisions are core requirements. Position is a member of the company’s Management Review Team.
Required Education, Experience and Skills:
- BSc in engineering discipline
- 8+ years of combined quality assurance, quality engineering and regulatory compliance management in the medical device industry including direct experience with software-based medical devices.
- Minimum of three years’ experience in a quality management role within a medical device company.
- Significant experience participating and leading regulatory audits.
- Ability to link technical and systems strategies into the overall business strategy for the company.
- Excellent interpersonal skills working across multiple divisions and sites and external resources.
- Excellent written and verbal communication skills.
- Excellent skills in managing both internal and outsourced technical resources.
Reports to: Complaints Investigations Engineer
Job Brief:
The Complaint Investigation Specialist supports the product complaint program including initial complaint assessment and identification of complaints related to adverse events. Analyzes incoming product complaints, determines requirements for investigation, investigates and evaluates complaints, and finds solutions together with cross-functional team to customer issues.
Duties and Responsibilities:
- Records and evaluates complaint submissions.
- Communicates with health care providers (HCP), HCP staff and/or patient to acquire relevant complaint information.
- Coordinates with internal departments (Customer Service, Regulatory Affairs, Quality Assurance,
- Medical Affairs, Manufacturing and R&D) to incorporate vital input into medical device event reports.
- Track receipt, investigation and closure of product complaints to ensure adherence to established timelines.
- Ensures timely processing of complaints.
- Investigate complaints and subsequently document the evaluation actions taken and conclusions reached using the defined report template.
- Where possible identify the root cause of the complaint and facilitate identification and implementation of corrective and preventive actions relative to a complaint investigation.
- Submit Quality Notification Reports to management for expedited complaints.
- Track and trend complaints, including provision of trend reviews / reports to customers, site and corporate management, and for Annual Product Records Reviews.
- Assure regulatory compliance of the complaint program is maintained.
- Support operations and quality management initiatives and objectives
Requirements
- Degree in Biomedical or Mechanical Engineering
- Prefer Candidates who have experience ~ testing medical devices in a medical device or biotech company.
- Previous experience working in a regulated environment and following SOP’s is a plus.
- Ability to work at a fast pace while maintaining quality work is also a plus.
- In addition, ability to perform routine / repetitive work.
- Candidates without previous industry experience will also be considered
Open Positions at ENvizion Inc. (US)
Location: Indiana
Job Description:
The Clinical Education Specialist will provide clinical demonstrations for use of ENvizion products in evaluation, implementation and on-site procedures. Demonstrations could be in formal educational settings as well as small‐group or individual presentations in patient‐care areas throughout a healthcare facility, to facilitate broad adoption of ENvizion products and technology.
The Clinical Education Specialist will play a key role in assisting the sales team in the acquisition of new business and the care and maintenance of existing customers.
Duties and Responsibilities:
- Generate and provide clinical demonstrations and education programs for the use of ENvizion products in evaluation, implementation and on-site procedures
- Work with Marketing to develop and deliver standardized onboarding and training materials for all ENvizion products
- Work with customers to introduce, promote, and increase the usage of ENvizion products throughout a customer facility
- Provide installation, related in‐service education and integration to new clients to ensure customer satisfaction
- Maintain awareness of medical and scientific literature to increase expertise related to the company’s products to perform as a subject matter expert
- Serve as a company’s liaison on clinical matters regarding the ENvizion products and provide information/feedback to the R&D and Marketing teams
- Represent the company and act as a course facilitator/presenter at various trade shows, training programs and events (including KOL development programs)
- Prepare the equipment, materials and supplies for all education programs
- Maintain all Certifications and necessary Hospital Vendor Credentialing
Required Education and Experience:
- At least a bachelor’s degree – a combination of life sciences/clinical degree (BSc) with a business/marketing education (MBA) is preferable
- At least 3 years of experience providing clinical support in Endoscopy, Operating Room or Special Procedures, preferably with intra-body navigation technologies
- Remote-based position; must travel (minimum of 75%)
Required Skills:
- Strong interpersonal skills and ability to interact effectively with different groups
- Excellent written and verbal communication skills including public speaking, presentation and training skills
- Excellent project management and organizational skills
- Ability to prioritize and manage multiple tasks
- Ability to solve problems and provide effective solutions
- Proactiveness and ability to act with autonomy and independence
Location: California
Job Description:
The Clinical Education Specialist will provide clinical demonstrations for use of ENvizion products in evaluation, implementation and on-site procedures. Demonstrations could be in formal educational settings as well as small‐group or individual presentations in patient‐care areas throughout a healthcare facility, to facilitate broad adoption of ENvizion products and technology.
The Clinical Education Specialist will play a key role in assisting the sales team in the acquisition of new business and the care and maintenance of existing customers.
Duties and Responsibilities:
- Generate and provide clinical demonstrations and education programs for the use of ENvizion products in evaluation, implementation and on-site procedures
- Work with Marketing to develop and deliver standardized onboarding and training materials for all ENvizion products
- Work with customers to introduce, promote, and increase the usage of ENvizion products throughout a customer facility
- Provide installation, related in‐service education and integration to new clients to ensure customer satisfaction
- Maintain awareness of medical and scientific literature to increase expertise related to the company’s products to perform as a subject matter expert
- Serve as a company’s liaison on clinical matters regarding the ENvizion products and provide information/feedback to the R&D and Marketing teams
- Represent the company and act as a course facilitator/presenter at various trade shows, training programs and events (including KOL development programs)
- Prepare the equipment, materials and supplies for all education programs
- Maintain all Certifications and necessary Hospital Vendor Credentialing
Required Education and Experience:
- At least a bachelor’s degree – a combination of life sciences/clinical degree (BSc) with a business/marketing education (MBA) is preferable
- At least 3 years of experience providing clinical support in Endoscopy, Operating Room or Special Procedures, preferably with intra-body navigation technologies
- Remote-based position; must travel (minimum of 75%)
Required Skills:
- Strong interpersonal skills and ability to interact effectively with different groups
- Excellent written and verbal communication skills including public speaking, presentation and training skills
- Excellent project management and organizational skills
- Ability to prioritize and manage multiple tasks
- Ability to solve problems and provide effective solutions
- Proactiveness and ability to act with autonomy and independence