Demo

QA/QC Inspector(Medical Device)

Kyyba Inc
Pleasanton, CA Full Time
POSTED ON 1/26/2025
AVAILABLE BEFORE 3/25/2025

Main Responsibilities:

  • Performs visual, dimensional and functional inspection and testing according to documented policies and procedures.
  • Records inspection and test data as prescribed by written instructions and procedures.
  • Recommends changes to policies and procedures.
  • Documents non-conformances in Non-Conforming Material Review system.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Education:

  • High School Diploma / GED or an equivalent combination of education and work experience

Experience Details:

  • Previous experience in Quality performing inspection. Prior medical device component inspection experience preferred.
  • Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing.
  • Training in blueprint reading and experience with inspection sampling techniques.
  • Knowledge of FDA, GMP, ISO 13485.
  • Good communication and computer skills, including Microsoft Word and Excel.
  • ASQ CMI certification preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Must be willing to work overtime as required, including weekends.
  • Ability to maintain regular and predictable attendance.

Job Type: Contract

Pay: $25.00 - $27.00 per hour

Expected hours: 40 per week

Benefits:

  • Paid time off

Schedule:

  • 8 hour shift
  • Monday to Friday

Experience:

  • Quality management: 2 years (Preferred)

Shift availability:

  • Day Shift (Preferred)

Ability to Commute:

  • Pleasanton, CA 94588 (Required)

Ability to Relocate:

  • Pleasanton, CA 94588: Relocate before starting work (Required)

Work Location: In person

Salary : $25 - $27

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