HQ Quality Assurance Specialist Vacancies in Shamir Israel – שמיר ישראל Shamir, Northern, Israel

Website Shamir Israel - שמיר ישראל

This Jobsfunter Listing is about Shamir Israel in Shamir, Northern, Israel 2022

About the job

Responsibility on mapping current QMS status Vs. implementing ISO 13485 (MD – Medical Device) Certification) according to group strategy, plan and quality policy.

Responsibility on implementing and/or enforcing ISO 13485 (MD Certification) requirements according to the mapping results.

  • Technical writing and updating of HQ SOPs according to MD regulation and corporate QMS
  • Admin of QMS SSoftwareW. such as Document Control app.
  • Execute tasks related to HQ Quality Projects
  • Conduct routine Quality trainings (new employees, yearly training to all HQ)
  • R&D and Engineering technical files Control (review)
  • Internal documentation review in regard toregarding regulatory requirements (such as product markings, labelling/packaging, marketing materials and artworks)
  • Support risk management processes to products control and critical process changes
  • Nonconformities management support and follow CAPAs
  • Post-market surveillance survey
  • Escorting external audits
  • Handling customer complaints for R&D products (e.g.e.g., Spark4)
  • Assisting in the process of yearly management review
  • Keep up to date with changes in Medical DeviceMD legislation, guidelines, and standards to support and advise in collaboration with group regulatory compliance manger

Report to: HQ Quality Manager & Global Quality Auditor

Job requirements:

  • Proven Knowledge/experience implementing with ISO 13485 & ISO 9001 based QMS
  • Technical writing, prepare Presentations, Reports, CAPA, KPI’S
  • University degree – advantage
  • Experience of at least 2 years in the medical device industry – advantage
  • Fluent English (Read, Write & Verbal – mandatory)
  • MS Office tools mastering (Word, Excel, Power Point, and more)

Personal skills:

  • Self-learner / Autodidact
  • Organizational skills and detail oriented
  • Good interpersonal skills, with the ability to communicate effectively with all levels, establishing and maintaining effective working relationships
  • Ability to work individually or in collaboration with others to accomplish tasks

This is a full time position.

Company: Shamir Israel – שמיר ישראל

Vacancy Type: Full-time 

Job Location:  Shamir, Northern, Israel

Application Deadline: N/A

Apply Here