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      • sydney, new south wales
      • contract
      • AU$75,000 - AU$100,000, per year, Will be paid on a hourly rate
      • full-time
      Work for a leading Medical Device firm;Become part of a well established QA team;Long term contract opportunity; Our client is the market leader in the Medical Device sector with a large international footprint. They currently have a long term contract opportunity or a QA. If you are looking for an opportunity that will stand out in your portfolio then don't miss out. Key Responsibilities:Mail out all the patient cards within 2 WD upon receiving;Day to day Quality check on incoming and outgoing products;Follow up complaint enquiry questions with Sales rep and ensure no pending complaints in SFDC more than 24 hrs;Register and deliver complaint samples within 2 WD upon receiving;Perform product return inspection 1~2 times per week or per urgent business request;Maintain Quality Q-hold log and manage Q-hold affected ANZ, including notifying SC/business stakeholders, notify 3PL for physical segregation and achieve Q-hold file;Quality data analysis, including but not limited, complaint (hot issues), action tracking of FCA, Q-hold NCR and CAPA;Compile all the quality related records for the past 12 months, including but not limited to QMR, FCA, Q-hold and complaint, etc;document internal audits and other quality assurance activitiesinvestigate customer complaints and non-conformance issuescollect and compile statistical quality dataOther tasks assigned by Quality Director; Qualification & Experience:Ideally, Engineering/Science tertiary qualification with working knowledge in complaints/ post market surveillance within a Medical device environment. 2- 3 + years of experience in vigilance reporting, quality systems regulations and post market activitiesPreferably an understanding of ISO9001, ISO 13485, FDA QSR, TGA/ Medsafe and local ANZ laws. Ideally strong background in data analytics and technical writing.Ability to work with local and international stakeholders in all levels. Remuneration & Work Rights:Must have full work rights for AustraliaLong term contract Role (Salary - $75,000 - $100,000 + super) will be paid on a hourly rate How to apply:Apply online, feel free to give me call 72 hours after application has been made: Vern Myburgh - 0449 229 194At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.
      Work for a leading Medical Device firm;Become part of a well established QA team;Long term contract opportunity; Our client is the market leader in the Medical Device sector with a large international footprint. They currently have a long term contract opportunity or a QA. If you are looking for an opportunity that will stand out in your portfolio then don't miss out. Key Responsibilities:Mail out all the patient cards within 2 WD upon receiving;Day to day Quality check on incoming and outgoing products;Follow up complaint enquiry questions with Sales rep and ensure no pending complaints in SFDC more than 24 hrs;Register and deliver complaint samples within 2 WD upon receiving;Perform product return inspection 1~2 times per week or per urgent business request;Maintain Quality Q-hold log and manage Q-hold affected ANZ, including notifying SC/business stakeholders, notify 3PL for physical segregation and achieve Q-hold file;Quality data analysis, including but not limited, complaint (hot issues), action tracking of FCA, Q-hold NCR and CAPA;Compile all the quality related records for the past 12 months, including but not limited to QMR, FCA, Q-hold and complaint, etc;document internal audits and other quality assurance activitiesinvestigate customer complaints and non-conformance issuescollect and compile statistical quality dataOther tasks assigned by Quality Director; Qualification & Experience:Ideally, Engineering/Science tertiary qualification with working knowledge in complaints/ post market surveillance within a Medical device environment. 2- 3 + years of experience in vigilance reporting, quality systems regulations and post market activitiesPreferably an understanding of ISO9001, ISO 13485, FDA QSR, TGA/ Medsafe and local ANZ laws. Ideally strong background in data analytics and technical writing.Ability to work with local and international stakeholders in all levels. Remuneration & Work Rights:Must have full work rights for AustraliaLong term contract Role (Salary - $75,000 - $100,000 + super) will be paid on a hourly rate How to apply:Apply online, feel free to give me call 72 hours after application has been made: Vern Myburgh - 0449 229 194At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.

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