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Penumbra, Inc.
Penumbra, Inc.
1 001 – 5 000 Xodimlar
Ishlab chiqarishSog‘liqni saqlashTibbiy sug‘urta
Penumbra, Inc. neyrovaskulyar va vaskulyar yordam uchun tibbiy texnologiyalarni ishlab chiqadi va ishlab chiqaradi. Uning mahsulotlar portfeliga trombektomiya qurilmalari, embolizatsiya kateterlari, MRT bilan mos tizimlar hamda o‘pka emboliyasini davolashda qon ivindilarini tezda olib tashlashga ko‘maklashish uchun mo‘ljallangan Lightning Flash 2.0 kabi dasturiy ta’minot bilan qo‘llab-quvvatlanadigan yechimlar kiradi. Kompaniya klinik dalillar va sog‘liqni saqlashga global nuqtai nazar asosida insult, miya anevrizmasi va yurak xuruji kabi jiddiy holatlarni davolash imkoniyatlarini rivojlantirishga e’tibor qaratadi.
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Kompaniyadagi ish o‘rinlari

Senior Supplier Quality and Compliance Analyst

Lead supplier audits and compliance activities at Penumbra, a global healthcare company developing medical device therapies.

USAmerika Qo‘shma ShtatlariCAKaliforniya
113 000 $ – 150 000 $ / yil
GibridTo‘liq stavkaSeniorTalab Qilinadigan Til: inglizchaMuvofiqlik

Tavsif

  • Oversee supplier audits and conduct regular supplier evaluations.
  • Coordinate the external supplier audit program, including data analysis, logistics, and quality management system documentation.
  • Assess supplier compliance and determine or recommend findings and follow-up actions.
  • Conduct supplier audits as an auditor or lead auditor.
  • Create strategic audit plans and coordinate audit scope with Supplier Quality Engineering.
  • Evaluate supplier changes, past audit results, and performance.
  • Check supplier procedures against internal and external compliance requirements.
  • Prepare audit reports that summarize results, conclusions, and recommendations.
  • Lead audit closeout meetings and follow-up activities.
  • Review supplier corrective-action responses and decide whether evidence, remediation, or escalation is needed.
  • Maintain the supplier audit schedule.
  • Lead the preparation, review, and revision of Supplier Quality Agreements.
  • Maintain the Approved Distributor List (ADL).
  • Address routine supplier quality and compliance issues.
  • Maintain Supplier Quality records.
  • Manage and drive nonconformance reports (NCRs) and corrective and preventive actions (CAPAs).
  • Refine supplier quality procedures, work instructions, and controls using audit trends, compliance risks, and supplier performance data.
  • Manage and release engineering change orders (ECOs) to improve processes and resolve supplier-related issues.
  • Coordinate quality matters with internal teams, customers, and suppliers.
  • Track industry requirements and trends in medical device quality compliance.
  • Communicate promptly with suppliers and distributors.
  • Mentor junior Supplier Quality and Compliance Analysts.

Talablar

  • Bachelor's degree in science or a related field and at least seven years of quality systems experience, preferably in medical devices, or an equivalent combination of education and demonstrated experience.
  • Experience with statistical methods and analysis.
  • Working knowledge of QSR, ISO, and other applicable regulations and laws.
  • Familiarity with current Good Manufacturing Practices in medical devices or an equivalent industry.
  • Proficiency in Microsoft Word, Excel, and PowerPoint.
  • Internal and external audit training and experience preferred.
  • ASQ Certified Quality Auditor (CQA) certification preferred.
  • Ability to manage multiple complex priorities under tight deadlines while maintaining attention to detail.
  • Strong verbal, written, and interpersonal communication skills.
  • Willingness and ability to work on site.
  • Ability to travel for business, potentially 0% to 25%.
  • Ability to lift and move up to 15 pounds.
  • Ability to move between buildings and floors.
  • Ability to remain seated and use a computer or standard office equipment for extended periods.
  • Ability to read, write emails, and prepare documents and spreadsheets.
  • Ability to move around the office and access file cabinets or supplies.
  • Ability to communicate and exchange accurate information with employees at all levels.

Imtiyozlar

  • Medical, dental, vision, life, AD&D, short-term disability, and long-term disability coverage.
  • 401(k) plan with an employer match.
  • Paid parental leave.
  • Eleven paid company holidays each year.
  • At least 15 accrued vacation days per year, with accrual increasing based on tenure.
  • Paid sick time in accordance with applicable laws.
  • Equity program, when applicable.
  • Collaborative team environment.
  • Learning opportunities.
  • Performance-based rewards.