We are always eager to meet motivated people who share our vision and wish to be part of our team.

To meet our clients’ expectations through the development, implementation, and delivery of their products we are currently looking to add to our team, the following:

QA Consultant

Job Description:

  • Assure compliance of Medical Device Quality Systems, ISO 13485:2003 and CFR21 Part 820. 

  • Develop and maintain/support QMS systems including under MDR and QSR (additional QMSs are an advantage such as Japan, Canada etc.).

  • Experience with MDSAP audits

  • Review and closure of Investigations on Company products and projects.

  • Provide specialized QA support as required as well as monitoring product and quality system performances and effectiveness

  • Assist in the selection, evaluation, qualification and maintenance of suppliers, vendors, and sub-contractors.

  • Support QA aspects of technology transfer of developed manufacturing processes.

  • Knowledge of DHF requirements is an advantage

  • Knowledge and experience with ISO 14971 is an advantage

 

Desired experience and skills:

 

  • A minimum of 3 years quality assurance leadership role in a medical device company

  • Highly Knowledgble of ISO 13485 requirements processes, and GMP productions rules in clean room environment

  • Experience with management of risk management processes, internal and external audits, Customer complaints, CAPA, Failure investigation, ECO, training, preparing company for external audits, etc. 

  • Experience with CE mark achievement and maintenance

  • IS 13485 Lead Auditor Certificate

  • Experience with FDA QSIT audits is an advantage

  • BSc or Higher Degree (Science advantage)

  • CQE is an advantage

  • Fluent English

RA Consultant

 

Job Description:

 

  • Define regulatory strategies and pathways.

  • Establish TF s for all classes I-II

  • Prepare FDA submissions

  • Submit global registrations worldwide: coordination and preparation of document packages for regulatory submissions.

  • Support design and development of products from a regulatory perspective.

  • Advise on standards, labelling and UDI requirements.

  • Participates in internal and external audits i.e. FDA inspections, notified body audits according to ISO13485, EUMDR, MDSAP.


Desired experience and skills:

 

  • 3+ years’ related experience in the medical device industry.

  • Experience in certified QMS environment per ISO13485 / FDA-QSR.

  • Bachelor's degree or higher in life science-related discipline, engineering, or law

  • Excellent English proficiency

Clinical Writer

 

Job Description:

Prepare Clinical and Regulatory documents for a variety of projects

 

Desired experience and skills:

 

  • Advanced degree in a life sciences or clinical discipline

  • English at mother tongue level.

  • Good writing skills

  • Familiarity with the use of online literature databases

  • Ability to interpret, evaluate, and communicate scientific and clinical data

  • Ability to work independently.

  • At least 2 years' experience in a medical device company

For additional information on posting above and to send your CV please mail to miriam.rot@hamada.co.il