Sr Eng, External Contract Manufacturer Quality

Singapore, Singapore

Job Description


Vantive: A New Company Built On Our LegacyBaxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.At Vantive, you will become part of a community of people who are focused, courageous and don\xe2\x80\x99t settle for the mediocre. Each of us are driven to help improve patients\xe2\x80\x99 lives worldwide. Join us as we revolutionize kidney care and other vital organ support.*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

  • Set Quality system requirements to contract manufacturers and suppliers, including those for services, indirect quality relevant purchases (non-BOM), and QS requirements for suppliers in global markets.
  • Perform Qualification of suppliers to medical device, pharmaceutical, combination devices, and/or biologics standards and oversee their placement on the Approved Supplier List (ASL), including ensuring the creation and maintenance of supporting evidence (Supplier Master File).
  • Conduct and oversee supplier audits-qualification and re-qualification, including finding closure; Collect, trend and report supplier quality metrics.
  • Improve/develop quality systems at selected suppliers for QMS and compliance improvement.
  • Develop controls processes, procedures and systems, including those for BOM, non-BOM, services, spare parts and Third Party Finished Goods.
  • Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures, including Quality Agreements.
  • Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes; Manage and oversee Purchasing controls CAPA, including root cause identification, and effective and timely closure.
  • Develop and/or deliver training to internal teams and suppliers.
  • Execute SCAR management, effective and timely closure and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs and NCR where needed.
  • Accountable for NCR as assigned, conducting NCR timeliness and effectiveness reviews, and trending for corrective/preventive actions.
  • Support Manufacturing, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable.
Participate in special projects and bubble assignments as defined by management and/or as part of personal development planReasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

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Job Detail

  • Job Id
    JD1434506
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Singapore, Singapore
  • Education
    Not mentioned