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Manager, Quality Control Testing - Interventional Oncology

External
onehealthineers logoOnehealthineers · S, Australia
$126K–$173K/yrFull-timeOn-siteToday
ComplianceCross-functional CollaborationDocumentationLeadershipSAFe
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Responsibilities

  • Lead daily QC testing operations supporting medical device manufacturing.
  • Manage and develop QC testing staff, including training, qualification, and performance management.
  • Ensure compliance with Quality System Regulations (QSR), internal procedures, and Good Documentation Practices.
  • Review and disposition QC test results, deviations, OOS/OOT events, and investigations.
  • Apply Statistical Process Control (SPC) methods to monitor process performance, detect trends, and drive improvements.
  • Support sterilization-related quality activities including review of records and acceptance criteria (Steam, EO, Gamma).
  • Support biocompatibility-related testing activities, risk assessments, and documentation.
  • Partner with Manufacturing, Engineering, Quality Assurance, Regulatory Affairs, and Supplier Quality.
  • Act as QC SME during internal, customer, and regulatory audits.
  • Drive continuous improvement initiatives to reduce variation, rework, and retesting.
  • What You will have:
  • Bachelor's degree in a scientific or engineering discipline or equivalent experience.
  • 8+ years of experience in Quality Control, laboratory operations, or medical device manufacturing.
  • 3+ years of people leadership experience.
  • Experience with medical device manufacturing and product release testing.
  • Working knowledge of Quality System Regulations (QSR) and ISO 13485.
  • Experience applying Statistical Process Control (SPC) techniques in a manufacturing environment.
  • Strong problem-solving, communication, and cross-functional collaboration skills.
  • What will set You apart:
  • Experience with sterilization methodologies: Steam, Ethylene Oxide (EO), and Gamma.
  • Experience supporting biocompatibility testing and biological safety activities.
  • Experience with microbiology, environmental monitoring, water testing, or cleanroom programs.
  • Experience supporting New Product Introduction (NPI) or manufacturing changes.
  • #LS-OS1
  • To find out more about Siemens Healthineers businesses, please visit our company page here .
  • The base pay range for this position is:
  • $125,920 - $173,140
  • Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
  • If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.
  • Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity a

Benefits

Health insuranceDental insuranceVision insurance401(k)

Additional Information

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Varian Medical Systems, a Siemens Healthineers company is hiring a Quality Control (QC) Testing Manager. In this role you will be responsible for leading on-site QC testing operations supporting the Interventional Oncology (IO) business in Austin, Texas. This role ensures that incoming materials, in-process samples, and finished medical devices meet defined specifications prior to release. The QC Testing Manager drives compliance with Quality System Regulations, supports sterilization and biocompatibility activities, applies Statistical Process Control (SPC), and partners cross-functionally to ensure product quality, patient safety, and business continuity. **This position is leveled as a Manager role designed to be onsite in Austin, TX. The Scope includes: people leadership responsibility and execution-focused accountability**


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