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Compliance Specialist

unlimited holidays
Remote: 
Hybrid
Contract: 
Full time
Experience: 
Mid-level (2-5 years)
Work from: 
Yoqneam (IL)

Offer summary

Qualifications:

Bachelor's degree in Life Sciences or Engineering, 2-3 years experience in compliance or quality assurance, In-depth knowledge of ISO 13485 and FDA regulations, Familiarity with Good Manufacturing Practices (GMP), Lead auditor certification is a plus.

Key responsabilities:

  • Coordinate and track CAPA system
  • Perform root cause analysis related to CAPA
  • Conduct internal and supplier audits
  • Create monthly analysis of audits and CAPA status
  • Support external audits and quality projects
Lumenis logo
Lumenis
1001 - 5000 Employees
About Lumenis
Energy to Healthcare Lumenis is a global leader in the field of minimally-invasive clinical solutions for the Surgical, Ophthalmology and Aesthetic markets, and is a world-renowned expert in developing and commercializing innovative energy-based technologies, including Laser, Intense Pulsed Light (IPL) and Radio-Frequency (RF). For nearly 50 years, Lumenis'​ ground-breaking products have redefined medical treatments and have set numerous technological and clinical gold-standards. Lumenis has successfully created solutions for previously untreatable conditions, as well as designed advanced technologies that have revolutionized existing treatment methods in each and every one of the verticals we operate in. Our drive for innovation stems from an uncompromising commitment to improving the health and well-being of our patients; addressing new and growing needs of aging populations; and in offering medical professionals cutting-edge solutions that fit seamlessly into the health-economics environment of the 21st century. A Leader with Great Assets in Attractive Growing Markets Innovative technology: Over 270 registered patents and more than 100 FDA clearances. Global reach: Active installed base of more than 80,000 systems and presence in over 100 countries. Strong brand: The Lumenis name and brand are associated with high quality among consumers. Partnership with key opinion leaders (KOL’s): Strong KOL support and commitment to research and development.
See more Lumenis offers

Job description

Description

  • Coordinating and tracking of CAPA system
  • Performing root cause analysis related to CAPA
  • Creating monthly analysis of CAPA status
  • Conducting internal and suppliers' audits
  • Follow up internal audits NCS tracker
  • Creating monthly analysis of internal audits status and NCS
  • Coordinating, performing and tracking suppliers’ audits
  • Creating monthly analysis of suppliers’ audits status
  • Updating and maintenance of quality procedures
  • Support external audits
  • Assisting with different quality projects


 


Requirements

  • Bachelor’s degree in a relevant field such as Life Sciences or Engineering.
  • 2-3 years of experience in compliance, regulatory affairs, or quality assurance within the medical device industry.
  • In-depth knowledge of ISO 13485, FDA regulations, and other relevant standards and regulations.
  • Familiarity with Good Manufacturing Practices (GMP). 
  • Lead auditor certification – an advantage.
  • Demonstrated skills in failure investigation and root cause analysis.
  • Strong documentation skills.
  • Fluent English - writing, reading, and speaking.
  • Strong understanding of quality management systems.
  • Excellent analytical and problem-solving skills.
  • Strong communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • High attention to detail and organizational skills. 

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
EnglishEnglish
Check out the description to know which languages are mandatory.

Hard Skills

Regulatory AffairsInternal DocumentationFailure AnalysisQuality Management SystemsISO 13485 StandardFDA RegulationsRoot Cause AnalysisCompliance Requirements

Other Skills

  • Problem Solving
  • Communication
  • Analytical Skills
  • Teamwork
  • Organizational Skills
  • Detail Oriented
  • Quality Assurance
  • Social Skills
Are you interested?

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