Job description

Position Name: Quality Engineer

Location: Northridge, CA

Duration: Fulltime

Degree in Mechanical, Materials or Biomedical Engineering with minimum 4 years of experience

· Hands on experience in Test Method Validation (TMV)

· Hands on experience (at least 2 yrs) in Manufacturing related CAPA Activities

· Hands on experience in Production Non-conformance (NCMR's)

· Working independently with the internal and external stakeholders for execution.

· Provides Quality Engineering support for commercial Medical products.

· Ensures changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.

· Utilizes quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.

· Navigates complex government regulations to include FDA & QSR requirements and guidance under 21 CFR820, ISO13485 and ISO14971.

Job Type: Full-time

Pay: $40.00 - $50.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Northridge, CA 91324: Reliably commute or willing to relocate with an employer-provided relocation package (Preferred)

Experience:

• ISO 9001: 1 year (Preferred)

Work Location: One location

Speak with the employer
+91 +15133994153

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