Medical Device Engineer (Supplier Quality Engineer) Job at Katalyst HealthCares and Life Sciences, Milpitas, CA

dW1kV3MvZHR6THNTVk8wNmFGNTFXcjhHUnc9PQ==
  • Katalyst HealthCares and Life Sciences
  • Milpitas, CA

Job Description

Roles & Responsibilities:

  • ISO 13485, Supplier Quality, NC/CAPA, Purchasing Control, 21 CFR 820, Part or Component Qualification, Equipment Verification & Validation activities.
  • Knowledge of Supplier Quality Related activities.
  • Exposure to ISO 13485 / 21 CFR 820 / Purchasing Control.
  • Equipment Verification/ Validation.
  • Part/Component Qualification.
  • Supplier Audit.
  • 10 + years of proven experience required (including 4+ years of medical devices domain & Supplier management experience preferred).
  • Experience with relevant Supplier Quality requirements is required.
  • Management of complete supplier Quality lifecycle.
  • Supplier Audit.
  • Part / Component Qualification.
  • Verification of Verification & Validation activities (hands on experience on IQ/OQ/PQ activities required).
  • Review & approval of supplier Documentations.
  • Supplier Site visits as and when required.
  • Supplier NC/CAPA lifecycle Management.
  • Weekly/Monthly Project progress dashboard generations.
  • Supplier related Risk Management.

Job Tags

Full time,

Similar Jobs

System One

Senior Event Technician (Audio) Job at System One

 ...Number:** JO-2505-2649**Primary Function**Join our new dynamic production team in Mountain View, California, where innovation in live...  ...complex equipment failures to appropriate in-house teams and assists with resolution to maintain service levels.+ Maintains audio-... 

Agility Personnel

Food Safety Quality Assurance Manager Job at Agility Personnel

 ...release, while also overseeing training programs for GMPs, HACCP, and Food Defense/Food Fraud.~Lead third-party audits (SQF and customer-...  ...overall reliability.~Maintain data on customer requirements, quality specifications, and reporting needs, while managing the quality... 

Capital Automotive Group

Security Guard Job at Capital Automotive Group

 ...overnight role? Capital Automotive Group is seeking an experienced Security Guard to join our team. This critical position helps ensure the...  ...service centers. This position requires availability during nights and weekends, specifically from 9:00 PM to 5:00 AM.... 

Sunset Studios

Studio Financial Analyst Job at Sunset Studios

 ...Hollywood, CA : At Hudson Pacific Properties, we provide best-in-class office & studio space to the biggest names in tech and media (Netflix & Amazon) and we're seeking a Studio Financial Analyst, to support our global Sunset Studios and Quixote production services... 

PwC

Data Engineer - Director Job at PwC

**Specialty/Competency:** Data, Analytics & AI**Industry/Sector:** Not Applicable**Time...  ...you need to lead and deliver value at this level include but are not limited to:+ Lead in...  ...PwC does not intend to hire experienced or entry level job seekers who will need, now or in...