Quality Systems Specialist I (Manufacturing)

Location: Onsite at the Corona, California branch, Monday–Friday, 8:00 a.m.–5:00 p.m.

Salary: $59,022.27–$94,457.18 per year

Company

hirify.global provides healthcare technology services and supports patient safety and product quality through regulated manufacturing and quality systems.

What you will do

• Manage QMS documentation, records, training and competency materials, document changes, and CAPAs.
• Author QMS documents, training materials, user guides, internal communications, and customer letters.
• Prepare and maintain Management Review materials and report quality indicators and metrics.
• Support internal and external ISO 13485 audits and monitor applicable FDA, ISO, and industry standards.
• Route and track Engineering Change Requests and Engineering Change Orders through company systems.
• Update part numbers, bills of materials, item assemblies, Device Master Records, blueprints, SOPs, and work instructions while coordinating engineering, quality, regulatory, and manufacturing teams.

Requirements

• Bachelor’s degree in life sciences, engineering, or technical communications is strongly preferred.
• 3–5 years of quality or other applicable experience.
• Knowledge of internal and external audits.
• Proficiency with Microsoft Office Suite and electronic ERP systems.
• Ability to sit, stand, lift, bend, and stoop repeatedly during the workday.
• Commitment to patient safety, product quality, and compliance with documented quality processes.

Nice to have

• ISO 13485 experience.
• Technical writing experience.

Culture & Benefits

• Health insurance options covering medical, dental, and vision care.
• Short- and long-term disability coverage, life insurance, flexible spending accounts, and health savings accounts.
• Paid time off and a 401(k) savings plan with employer matching.
• Tuition reimbursement, employee discounts, Daily Pay, employee assistance, and wellness programs.
• Vaccinations may be required based on customer or company requirements; required vaccinations are provided at a participating clinic at the company’s expense.