Job Description:
The SQE is responsible for determination of product and process specifications via validations to assure the company procedures and products are in compliance to POCARED requirements as well as applicable regulatory requirements and the defined standards. The SQE will conduct and/or oversee equipment, software and process validations and assist with investigations required for non-conformance handling. The SQE will conduct and/or oversee the maintenance of POCARED equipment including calibration. The SQE will also participate in quality audits with QA Manager and other department managers as necessary. She/he will assist and collaborate with other departments such as R&D, Operations, Manufacturing, Quality Control, Clinical Affairs, and Regulatory to ensure continued compliance, product quality, and safety. The individual will lead various quality projects as needed and will report to the QA Manager.
The SQE is responsible for determination of product and process specifications via validations to assure the company procedures and products are in compliance to POCARED requirements as well as applicable regulatory requirements and the defined standards. The SQE will conduct and/or oversee equipment, software and process validations and assist with investigations required for non-conformance handling. The SQE will conduct and/or oversee the maintenance of POCARED equipment including calibration. The SQE will also participate in quality audits with QA Manager and other department managers as necessary. She/he will assist and collaborate with other departments such as R&D, Operations, Manufacturing, Quality Control, Clinical Affairs, and Regulatory to ensure continued compliance, product quality, and safety. The individual will lead various quality projects as needed and will report to the QA Manager.
Detailed Job expectations:
- Reviews design and development documentation and records for compliance to internal procedures and regulations and guidance for validation activities.
- Participates in device risk management activities according to ISO 14971 and other requirements.
- Aids in establishing statistical controls in development and transfer to manufacturing processes.
- Reviews and/or leads activities related to Design Verification, Design and Process Validation and Design Transfer of Medical Devices and related software. Conducts Qualification Activities (IQ, OQ, PQ) for production and quality control related instrumentation and equipment. Develops and documents product and process specifications and tolerances to support Design Transfer to Manufacturing.
- Collects and performs analysis of quality data. Monitors quality trends and identifies and resolves department and quality management system-level issues.
- Review related non-conformance reports, CAPAs, Deviations, NCMRs, and ECOs.
Detailed Knowledge and Skills Required:
- Must have working knowledge of ISO 13485:2016, cGMP/CFR 21 Part 820, and ISO 14971:2019
- Experienced with process and equipment validation
- Strong interpersonal, verbal and written communication skills
- Strong analytical and problem-solving skills
- Time management skills with ability to handle multiple tasks simultaneously.
- Self-motivated, proactive, highly organized and able to work with minimum supervision
- Excellent organizational skills and attention to details
- Proficiency in MS Office, electronic document control, other electronic quality system tools
- English – high level
Experience:
- At least 3 years of quality assurance related experience, preferably within the medical device or in vitro diagnostic device industry. Experience in Design and Development and Manufacturing quality assurance processes.
- Work experience with Medical Device Quality Systems (ISO 13485:2016, CFR 21 Part 820, ISO 14971)
- Experience with collection of relevant quality data and use of statistical analysis methods to create meaningful quality information.
- Experience working with QMS Software Systems
- Experience with non-conformance investigations of medical devices or in vitro diagnostic devices.
- Experience writing process documentation in accordance with applicable regulatory requirements in the medical device or in vitro diagnostic device industry.
Education:
- A Bachelor’s degree in engineering, or quality engineering.
Certified Quality Engineer (CQE)
Job Description
The controller is managing the finance department as well responsible for the daily activities of the accounting department as the Financial and Tax reporting, as well responsible for preparing and monitoring the company Business Plan .
In this position the controller will maintain and establish financial procedures, controls, policies and reporting systems.
The controller is managing the finance department as well responsible for the daily activities of the accounting department as the Financial and Tax reporting, as well responsible for preparing and monitoring the company Business Plan .
In this position the controller will maintain and establish financial procedures, controls, policies and reporting systems.
Detailed Job expectations
- Prepare Yearly and Quarterly financial statements.
- Prepare timely Tax reports.
- Establish and implement SOX internal controls and procedures.
- Preparing monthly and financial reporting process including account analysis and accounts reconciliations.
- Preparing Cash status and the relevant reports.
- Supervising and supporting the daily accounting department tasks
- Preparing the Company yearly Budget and monitoring it.
Detailed Knowledge and Skills Required
- BA Degree in Accounting.
- Certified accountant.
- Independent with strong communication and interpersonal skills.
- Fluent English.
- Microsoft Excel ,Word and PowerPoint skills
Experience:
- Graduate of the big 4 audit firms in IL.
- Knowledge and experience in preparing the financial statements according to the US GAAP.
- At least two years of experience with public companies, as auditor or in the finance team.
- Experience with SOX – advantage
- Experience with ERP systems – advantage
- At least one role as a Controller in a Company
Main Accountabilities:
- To organize and carry out the training of new staff.
- To direct, guide and perform fungal and bacterial analysis
- To manage the availability of staff, equipment and consumables within the laboratory, thus ensuring that all the work can be completed appropriately.
- To ensure that staff resource is suitably split within the laboratory to enable all work to be completed as required.
- To ensure that training protocols are suitably implemented within the laboratory to provide a balanced (but increasing) level of competency within all analytical areas.
- To provide sound Microbiological advise to the R&D team .
- To ensure compliance with all the internal and external quality systems
- To prepare, review and implement SOPs and research protocols.
Requirements
- Degree in Medical Technology, Clinical Lab Science, or related science (Microbiology, Biology etc.)
- 8+ years experience working in a laboratory environment (preferred both clinical and research)
- 3+ years experience of supervising staff.
- Experience of working in a regulated environment.
- Strong background in bacteriology
- The ability to work accurately under pressure
- A good standard of verbal and written communication (English and Hebrew)
- Good computer skills
Job Description
Individual will be responsible for successful product transfer process from R&D to Production and ensuring engineering requirements are built into POCARED’s products. The individual will report to the Engineering manager. Individual’s focus will be POCARED’s Instrument manufacturability. Individual will develop with R&D relevant handshake process for product transition from R&D to Production.
Individual will be responsible for successful product transfer process from R&D to Production and ensuring engineering requirements are built into POCARED’s products. The individual will report to the Engineering manager. Individual’s focus will be POCARED’s Instrument manufacturability. Individual will develop with R&D relevant handshake process for product transition from R&D to Production.
Detailed Job expectations
- Develop Transition plans from R&D to Production
- Execute Transition plan while building Instrument frozen Master Record
- Support manufacturing department with building production line
- Support investigation in the event of customer complaint
- Support corrective action in the event of a product recall and update associate Engineering process
- In the event of a product recall, work with the VP of Regulatory to develop a corrective action plan
- Manage multiply interfaces with R&D, Manufacturing, Sub contractor and Quality functions
Detailed Knowledge and Skills Required
- Electronic/Mechanical Engineering education
- Technical hands on capabilities
- Project management knowledge
- Ability to dive into details while remaining on project execution outcome
- Process validation
- Good communication skills (English a must)
- Good leadership skills of both people and cross organizational processes in an effective, assertive and cooperative manner
Experience:
- At least 5 years working at NPI engineer manager position.
- Working in a company with multi-disciplinary products across the spectrum of instruments, software and consumables
- Proven experience in establishing and improving engineering process
- Former experience in people or project management
- Past work in Medical device company is a major advantage
Education:
- Engineering degree in related field
The Experience Storekeeper is responsible for store day to day activities and business process. Business process includes and not limited to incoming process, storage conditions and locations; goods issue to customers, back up for Israeli logistics coordinator and managing store associate information system transactions. This position reports to the Stores and logistics manager.
Detailed Job expectations
- Manage daily store tasks such receiving, storage, packaging, cycle counts, and issuing
- Ensure organized store areas, proper storage conditions and controlled access.
- Manage all store transactions on ERP and store metric on electronic media
- Ensure accurate inventories
Detailed Knowledge and Skills Required
- Follow procedures Meticulously
- Independent
- Highly organized
- High awareness to safety and quality
- Ability to work with heavy boxes and crates using appropriate work aids
- Good English – Read/Write is a must.
- Good interpersonal skills.
- Experience with stores information systems. (Experience with Oracle ERP systems is an advantage.)
Experience:
- 3-5+ years of actual work experience in computerized store
- Medical device / Pharma companies is an advantage
- Component parts experience is an advantage
Education:
- 12 years and/or technician
- 1. Technical background is an advantage
The Company Admin is responsible for the company administration and office reception. Job includes attending POCARED’s office space reception, support multiply administration tasks and others for different activities and manage the office environment.
Detailed Job expectations
- Be the recipients in the office’s front desk during working hours (08:00-17:00)
- Perform different administration tasks such as hotel reservations, document editing, mailing, marketing events, exhibitions, follow ups, safety plans, purchasing requisitions among others.
- Manage building /facility suppliers performance
- Ensure workable office environment including work needs (chair, other accessories)
- Operation’s data key entering and quality documentation follow up
Detailed Knowledge and Skills Required
- Highly organized
- Very good interpersonal skills
- Independent work capability
- Follows procedures
- Microsoft office usage knowledge and experience
Experience:
- More than 4 years of relevant experience in administrative tasks
- Experience with global company is an advantage
- ERP information system experience is an advantage
Education:
- Minimum high school graduation