Quality Assurance Specialist (Manufacturing)

TL;DR

Quality Assurance Specialist (Manufacturing): Developing and maintaining the Quality Management System (QMS) for microbiology diagnostic tests with an accent on regulatory compliance and ISO standards. Focus on driving CAPA processes, executing validation protocols (IQ/OQ/PQ), and managing root-cause investigations to ensure product safety.

Location: Onsite in Camarillo, CA, US

Salary: $70,304–$85,000 base salary

Company

hirify.global provides rapid microbiology diagnostic tests and solutions for mission-critical processes, primarily focusing on global food safety.

What you will do

• Standardize and continuously improve the Quality Management System (QMS) to ensure full regulatory compliance.
• Manage daily quality processes, including nonconformances, deviations, change controls, and risk assessments.
• Drive Corrective and Preventive Action (CAPA) and Supplier Corrective Action Requests (SCAR) from root-cause analysis to closure.
• Support validation protocols (IQ/OQ/PQ) for production equipment, software, and manufacturing processes.
• Participate in internal, supplier, and external audits, assisting with preparation and follow-up.
• Handle customer complaint investigations, including data collection and trend analysis.

Requirements

• Bachelor’s Degree in Science, Engineering, Business or a related field.
• Minimum of 2 years of hands-on experience in a fast-paced manufacturing or production environment.
• Experience working within an ISO certified facility (preferably ISO 9001 and/or ISO 13485).
• Demonstrated experience executing root cause investigations and facilitating CAPA.
• Intermediate knowledge of Microsoft Office (Outlook, Word, Excel, Visio, PowerPoint) and Adobe Acrobat.
• Must be able to work onsite Monday through Friday in the Camarillo office.

Nice to have

• ISO 9001 or ISO 13485 Lead Auditor Certification.

Culture & Benefits

• 15 days of PTO and 9 paid company holidays.
• Comprehensive medical insurance with HSA employer contribution, Dental, and Vision.
• 401(k) with Safe Harbor and Profit-Sharing employer contributions.
• Tuition Reimbursement program and charitable contribution matching.
• Company-paid Life Insurance, Short-Term and Long-Term Disability.