Overview
Quality Inspector Jobs in Santa Ana, CA at Sumeru INC
Location: Onsite in Alachua, FL
RTI Surgical is now Evergen!
This rebrand reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale.
About Evergen:
Evergen (formally RTI Surgical) is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ.
Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM
JOB RESPONSIBILITIES
Provides quality support for the Quality Engineering functions such as manufacturing, sterility assurance, or supplier quality
Performs investigations for product or supplier nonconformance and process noncompliance issues and documents exceptions appropriately in the Corrective Action / Preventative Action (CAPA) System
Performs CAPA investigations using problem solving methodologies and a high attention to detail
Participates in the review and disposition of non-conforming product or controlled process inputs including the Product Quality Review Board (PQRB), returns, and complaints
Supports the review of validation documentation or new supplier qualification activities quickly and accurately in collaboration with engineers
Performs audits of products or processes and documents the results appropriately
Assists in the Change Management function including maintaining relevant work instructions, Standard Operations Procedures (SOPs), and other quality documentation
Performs product acceptance testing, quality inspections, data entry, and data corrections quickly and efficiently
May provide support for environmental monitoring investigations, documentation of quality inspections on controlled suppliers, or supports the Approved Supplier List monitoring activities
Identifies and supports process improvement initiatives and implementation
May support projects as a quality resource as assigned
Other duties as assigned
Education
High School diploma or equivalent
Experience
3-6 years of experience in quality assurance or quality control
Additional education may substitute for experience requirement
Certification
ASQ certification preferred
Skills
Strong verbal and written communication
Microsoft Office Suite, basic Excel
Technical Writing
Investigations
SAFETY
Physical Requirement
Move or lift objects up to 25 pounds
Frequent (>75%) stationary position (standing or sitting) while utilizing digital
Frequent (>75%) fine manipulation using hands and fingers (typing, opening,writing, clicking, paper sorting, etc.)
Working Environment
Onsite: Office environment with assigned workstation
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Title: Quality Inspector
Company: Sumeru INC
Location: Santa Ana, CA
