Senior QC Inspector
San Jose, CA 
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Posted 6 days ago
Job Description
Circulation, ZOLLMED.com

At ZOLL, we're passionate about improving patient outcomes and helping save lives.

We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Acute CareTechnologydivisionof ZOLLMedical Corporation is focused on "beating heart" therapies for hospitals. Post-cardiac arrest, STEMI heart attack, and severe fever are some of the applications of ZOLL's unique devices. Fully integrated, ZOLL Circulation researches, develops, manufactures, and sells novel technologies includes ZOLL Temperature Management Solutions and TherOx SSO2 Therapy. Temperature Management Solutions empower physicians to "prescribe" a temperature and achieve it. TherOx SSO2 Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks.

Job Type
On Site

Job Summary
Provide analysis and support for incoming, in-process, and final inspection/testing. Duties include routine inspections, first article inspections, identifying non-conformance trends, and documentation review. Performing process improvements for IQC flow

Essential Functions

  • Provide key training to IQC inspectors including GD&T and advanced measurement tools
  • Manage the Smartscope Inspection Program including:
  • Maintaining the program development schedule
  • Developing training curriculum for the Smartscope System
  • Manage the calibration and preventive maintenance of the system
  • Creating fixturing as needed for the measurement of components on the Smartscope
  • Perform FAI using the Smartscope system
  • Complete First Article Inspections including supporting documentation
  • Perform in-process and final inspection/testing of devices
  • Perform review of device history records and release products
  • Support inspection of engineering prototypes
  • Provide guidance, training, and instructions for inspectors
  • Document nonconformance's
  • Create inspection instructions
  • Create document change orders
  • Perform internal calibrations
  • Comply with all policies and standards.
  • Any other job responsibilities as assigned by management and subject to modification


Required/Preferred Education and Experience

  • 4-6 years of Inspection and testing experience in the Medical Device Industry preferred
  • Minimum of 5+ years of related experience in the medical device industry
  • Experience in using CMM/Vision measurement systems
  • Experience in GD&T
  • Experience in a medical device, FDA QSR regulated industry, including ISO 13485 requirements
  • Experience inspecting electronics, mechanical and cable assemblies, as well as printed material and labeling.
  • High School Diploma or Associate's degree preferred


Knowledge, Skills and Abilities

  • IPC 610 & 620 or equivalent experience
  • ANSI Z1.4 Sampling Plans or equivalent experience
  • Experience using Excel, Word, Access
  • Strong communication and interpersonal skills
  • Ability to work independently with little supervision
  • Experience training and instructing others


Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Standing - Constantly
  • Walking - Constantly
  • Sitting - Occasionally
  • Lifting - Constantly
  • Carrying - Constantly
  • Pushing - Constantly
  • Pulling - Constantly
  • Talking - Occasionally
  • Hearing - Frequently
  • Repetitive Motions - Constantly
  • Eye/Hand/Foot Coordination - Constantly


Working Conditions

  • Extreme cold - Occasionally
  • Extreme heat - Occasionally
  • Humidity - Occasionally
  • Wet - Occasionally
  • Noise - Frequently


ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

The hourly rate for this position can range from $25 - $31. The actual compensation may vary outside of this range depending on geographic location, work experience, education, and skill level.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.


ZOLL LifeVest is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
4 to 6 years
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