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QA/RA Manager




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QA/RA Manager Medical Device

For a big international client in Noord-Holland, Netherlands we are looking for a QA officer who has experience and passion for quality within the Medical Device industry and is available ASAP


  • Oversee, supervise and manage the QA/RA activities related to all products and processes
  • Development, execute and maintain Quality Management Systems affecting the overall compliance, sales, distribution, design and manufacturing of OHE products and services in the EMEA.
  • Recommend, coordinate and support the positions, responses and action plans to implement and ensure compliance to current and new regulatory developments
  • Manage the QA/RA team, including recruitment, training and performance evaluations
  • Manage Product Documentation and Product labelling review and approval
  • Manage all activities related to medical claims review and approval
  • Manage customer complaints, including nature/cause/ effect analysis and CAPA management
  • Manage the supplier’s production quality control and regulatory compliance improvement programs
  • Manage sub-contracting contract review


  • Working experience in an international Medical Device organization
  • In depth Knowledge of and practical experience regarding the implementation of Quality Management systems and Medical Device (ISO 13485), Medical Device Directive EEC 93/42 and the Medical Device Regulations (EU) 2017/745
  • Knowledge of and experience regarding technical testing process of medical devices
  • Knowledge of and experience regarding Production Quality & Process Validation
  • Knowledge of and experience regarding clinical validation and testing of medical devices
  • University degree in a relevant field
  • Proficient in the English language, both written and verbal

Period: 12 months

Start date: A.S.A.P.

Location: Noord-Holland

If you’re interested in the position, please reply on this vacancy with your most recent CV (English) letter of motivation and availability!

Ps: Did you also know that we offer a generous referral scheme because great people know great people, right!

For further information, please contact Olaf Teeling at +31 (0)20 20 44 502 or by email (CV attached) at o.teeling@panda-int.com

Company Info
Panda International
Kleine Gartmanplantsoen 21
Amsterdam, Noord-Holland, Netherlands
Phone: +31 20 20 44 502
Web Site: http://www.panda-int.com/
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