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

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

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