Join the Li-Med team

  1. Home
  2. Vision
  3. Careers

Are you an experienced QA/RA professional?

Who are we? We are a Quality and Regulatory consulting company managed by Asaf Azulay.
Where? Our office is in Petah Tikvah, but our clients are located all over the central part of Israel (from Yokneam in the north to Yavne in the south).
What do we do? We work with clients in the Medical Device field to build and implement their quality management system, as well as prepare regulatory strategy plans and files.

QA/RA Project Manager job #114

Job description:

  • Manage the relationship with the client and all stakeholders, create, maintain & approve work plans
  • Coordinate internal resources and third parties/vendors for the flawless execution of projects
  • Perform internal and suppliers audit and prepare the company for regulatory audits
  • Responsible for all QA/RA activities in the respective client management system including: CAPA, MRB, ECO, training and supplier management
  • Create Quality Metrics and prepare for Management Review.
  • Develop training and documentation materials for production (e.g., work instructions, verification and validation reports) to enable the seamless knowledge transfer of project and manufacturing processes
  • Establish and maintain design control processes including risk management
  • Responsible for contact with regulatory authorities including: regulatory submission and compliance
  • Provide guidance and support for junior QA/RA specialist

Job requirements:

  • At least 5 years’ experience with maintain quality system in a medical device/pharmaceutical industry
  • At least 2 years’ experience and knowledge in medical device regulation (CE and FDA at least)
  • Experience in writing and maintain DHF related documents
  • Experience in writing and maintaining design controls and risk management processes
  • Experience in writing and implementing Quality Procedures
  • Experience in quality related processes such as: CAPAs, MRB/NCR, in process tests and final release
  • Knowledge in industry related standards and their interpretation
  • Experience in writing and submitting regulatory documents
  • Participation in regulatory audits

Quick learning ability and independent workers

Languages: proficient in Hebrew and English (reading, writing and speaking)

Please send your CV to asaf@li-med.com

**Only suitable candidates will be contacted.

V&V and Quality Engineer job #115

Job Description:  

  • Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
  • Use root cause analysis tool and/or work with supplier using root cause analysis tool to investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all types of production processes.   Create an action plan of corrective action and complete/coordinate work and reports in order to resolve the issue.
  • Develop training and documentation materials for production (e.g., work instructions, verification and validation reports) to enable the seamless knowledge transfer of project and manufacturing processes
  • Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
  • Assist with performing internal and supplier Quality System, process and product audits
  • Visit suppliers and follow up on identified corrective actions and/or other improvements for CM and suppliers.

Job Requirements:

  • Experience in Medical Device verification and validation activities:
    • Writing product V&V plans, protocols and reports
    • Implementing statistical methods
  • Experience in process validation activities (IQ/OQ/PQ) such as: equipment validation, cleaning validation, sealing validation.
  • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
  • Solid problem-solving, organizational, analytical and critical thinking skills
  • Knowledge of ISO 13485 and FDA requirements processes
  • Familiar with the following Quality tools: Risk Analysis (FMEA), Cause & Effect Analysis, Good Documentation Practices.
  • Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
  • Good computer skills in usage of MS Office Suite
  • Good documentation, English/Hebrew communication skills and interpersonal

Please send your CV to asaf@li-med.com

**Only suitable candidates will be contacted.

V&V and Quality Engineer job #115

Job Description:  

  • Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
  • Use root cause analysis tool and/or work with supplier using root cause analysis tool to investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all types of production processes.   Create an action plan of corrective action and complete/coordinate work and reports in order to resolve the issue.
  • Develop training and documentation materials for production (e.g., work instructions, verification and validation reports) to enable the seamless knowledge transfer of project and manufacturing processes
  • Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
  • Assist with performing internal and supplier Quality System, process and product audits
  • Visit suppliers and follow up on identified corrective actions and/or other improvements for CM and suppliers.

Job Requirements:

  • Experience in Medical Device verification and validation activities:
    • Writing product V&V plans, protocols and reports
    • Implementing statistical methods
  • Experience in process validation activities (IQ/OQ/PQ) such as: equipment validation, cleaning validation, sealing validation.
  • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
  • Solid problem-solving, organizational, analytical and critical thinking skills
  • Knowledge of ISO 13485 and FDA requirements processes
  • Familiar with the following Quality tools: Risk Analysis (FMEA), Cause & Effect Analysis, Good Documentation Practices.
  • Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
  • Good computer skills in usage of MS Office Suite
  • Good documentation, English/Hebrew communication skills and interpersonal

Please send your CV to asaf@li-med.com

**Only suitable candidates will be contacted.

Quality expert requirements job #117

Job description:

  • Provide QA resource to product support to ensure regulatory compliance of pre and post market products.
  • Manage QA process in various medical device companies
  • Ensure that projects to develop medical devices follow applicable company policies, procedures, standards and regulations.
  • Responsible for device release
  • Support the investigation of vigilance and reportable events and reporting of the results of the investigations to corporate and regulatory authorities.
  • Assist in risk management and design control processes and provide support for design quality assurance activities on medical device projects
  • Assist with testing and V&V activities throughout the product lifecycle
  • Prepare for and participate in project and quality systems audits and inspections.
  • Support the QA/RA Manager in quality and regulatory decisions as required and other relevant tasks as may be reasonably requested of the QA/RA Manager.

Job requirements:

  • B.Sc. in Mechanical Engineering/ Biomedical Engineering/ Biotechnology/ Life Sciences or any related field
  • At least 2 years of experience with medical device Quality and Regulatory requirements (ISO13485, FDA, MDD)
  • Experience in writing and implementing Quality Procedures
  • Experience in quality related processes such as: CAPAs, MRB/NCR, in process tests and final release
  • Experience in supporting R&D and Manufacturing departments, handling ECOs, DHFs, DMRs
  • Participation in regulatory audits – an advantage
  • Knowledge and experience in V&V – an advantage

Quick learning ability and independent workers

Languages: proficient in Hebrew and English (reading, writing and speaking)

Please send your CV to asaf@li-med.com

**Only suitable candidates will be contacted.

Regulatory affairs expert requirements job #118

Job description:

  • Assist in compiling technical documentation and regulatory submissions
  • Write and maintain regulatory documents
  • Provide regulatory support for R&D and Engineering departments
  • Support the implementation of the project’s quality, regulatory and compliance policy
  • Manage compliance to FDA/EU regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations

Job requirements:

  • B.Sc. in Mechanical Engineering/ Biomedical Engineering/ Biotechnology/ Life Sciences or any related field
  • At least 2 years of experience with medical device world-wide regulation requirements (CE, FDA) – a must
  • Knowledge in industry related standards and their interpretation
  • Experience in writing and submitting regulatory documents
  • Participation in regulatory audits – an advantage

Quick learning ability and independent workers

Languages: proficient in Hebrew and English (reading, writing and speaking)

Please send your CV to asaf@li-med.com

**Only suitable candidates will be contacted

Feel free to contact us:

  • This field is for validation purposes and should be left unchanged.
Menu