Quality Engineer

• Type: Direct Hire
• Job #39731
• City: Camarillo
• State: California

We are seeking a Quality Engineer to support the development, manufacturing, and commercialization of biotechnology products. In this role you will incorporate your knowledge of medical device design control, GMP regulations and validation at a fast-growing biotech company.

Terms: Direct Hire

Benefits: Medical, Dental, Vision, PTO, Paid Holidays, Growth & Mentorship, 401k

Salary: $76,000 – 114,000

Responsibilities

• Provide analysis for impact to product quality and validation to support changes, investigations, CAPA, and manufacturing processes.
• Quality contact for validation of manufacturing process, facility, and equipment.
• Supports and own elements of the validation program
• Manage validation and testing for product, equipment, and facility.
• Organize lab results for testing of bioburden, particulates, endotoxin, biocompatibility, and extractables on the product

Requirements

• Bachelor’s degree in an engineering field
• 2+ years in a Quality Engineering or Validation role, OR 5+ years for a Senior level title
• 2+ years of experience working with products regulated by GMP/biopharma/aerospace
• ISO 9001 experience is a plus