Quality Documentation Specialist – QMS & ISO (Onsite)

Agiliti; Corona (CA); On-site; USD 59,022 - 94,457; Full time

Benefits offered by this job

Health insurance options for Medical, Dental & Vision plans

401K Savings Plan with employer match

Tuition Reimbursement

Employee Assistance Program

Job summary

Agiliti is searching for a Quality Systems Specialist I in Corona, CA. This position encompasses various Quality Management System activities, including document change management and compliance with FDA ISO standards.

The ideal candidate will possess a bachelor’s degree, 3-5 years of relevant experience, and proficiency in technical writing and ERP systems. Agiliti promotes a culture of patient safety and quality assurance.

The role offers a comprehensive benefits package and is primarily onsite.

Qualifications

• 3-5 years of quality or relevant experience is essential.
• Ability to perform physical tasks like lift, bend, and stand frequently.

Responsibilities

• Participate in QMS activities including document change management.
• Assist in internal and external ISO 13485 audits.
• Liaise between engineering, quality, regulatory, and manufacturing teams.

Skills

Knowledge of internal and external audit

ISO 13485 experience

Proficient computer skills in MS Office Suite and ERP

Technical writing experience

Commitment to patient safety and product quality

Education

Bachelor’s degree in life sciences, engineering or technical communications

Tools

ERP system

MS Office Suite

Job description

Agiliti is searching for a Quality Systems Specialist I in Corona, CA. This position encompasses various Quality Management System activities, including document change management and compliance with FDA ISO standards.

The ideal candidate will possess a bachelor’s degree, 3-5 years of relevant experience, and proficiency in technical writing and ERP systems. Agiliti promotes a culture of patient safety and quality assurance.

The role offers a comprehensive benefits package and is primarily onsite.