Manufacturing Document Clerk

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

Quality Systems Specialist I

Agiliti – Corona, CA – Onsite role. General work hours: Monday – Friday, 8:00 am – 5:00 pm.

Responsibilities

• Participate in all Quality Management System (QMS) activities including document change management, records management, training/competency and Corrective and Preventive Actions (CAPAs).
• Explain scientific and technical ideas by authoring clear and concise QMS documents, training materials, user guides, internal communications, and customer letters through structured writing and content management.
• Participate in the creation and maintenance of Management Review materials, including oversight and reporting of Quality Indicators (QIs)/metrics.
• Assist in internal and external ISO 13485 audits of QMS.
• Monitor governmental and associated industry organizations’ standards, guidelines, and policies (ISO, FDA, TJC, DNV, NFPA, CMS, AAMI, CDC, AABB, etc.).

Additional Responsibilities

• Processing Documentation: routing and tracking Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs) through the company’s system.
• System Updates: entering and updating part numbers, Bills of Materials (BOMs), and item assemblies in Product Lifecycle Management (PLM) or Enterprise Resource Planning (ERP).
• Compliance & Traceability: ensuring all changes comply with FDA 21 CFR Part 821/820 and ISO 13485 standards, maintaining exhaustive audit trails and updated Device Master Records (DMRs).
• Cross‑Functional Coordination: acting as a liaison between engineering, quality assurance, regulatory affairs, and manufacturing teams to ensure alignment on product revisions.
• Notification and Distribution: distributing updated blueprints, standard operating procedures (SOPs), and work instructions to affected departments.

Required Experience

• Bachelor’s degree in life sciences, engineering or technical communications strongly preferred.
• 3‑5 years of quality or other applicable experience.

Required Skills and Abilities

• Knowledge of internal and external audit.
• ISO 13485 experience preferred.
• Proficient computer skills in MS Office Suite and an electronic ERP system.
• Ability to sit, stand, lift, bend, and stoop numerous times throughout the day.
• Technical writing experience preferred.
• Demonstrated commitment to patient safety and product quality by maintaining compliance with QMS, Quality Policy, and all documented quality processes and procedures.

Pay Range for All Locations Listed

$59,022.27 – $94,457.18

Equal Employment Opportunity Statement

It is the policy of Agiliti to provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, physical or mental disability, genetic information, marital status, status as a veteran, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws. In addition, Agiliti will provide reasonable accommodations for qualified individuals with disabilities. Agiliti strictly prohibits any form of retaliation against individuals who make good faith reports of alleged violations of this policy or who cooperate in Agiliti’s investigation of such reports.

Benefits

Agiliti offers a robust suite of benefits for regular, full‑time, non‑union employees including health insurance options for Medical, Dental & Vision plans, Short‑ and Long‑Term Disability plans, Flexible Spending Accounts, Health Savings Accounts, Life Insurance Options, Paid Time Off, 401K Savings Plan with employer match, Employee Discounts, Tuition Reimbursement, Daily Pay program, Employee Assistance Program, and wellness programs.

Vaccination Requirements

You may be required to obtain certain vaccinations, or provide proof of current vaccination status, based on customer and/or company requirements. If vaccination is required, Agiliti will provide specific directions and cover the expense at a participating clinic. This includes the COVID‑19 vaccination.

Location

Corona, CA Branch – Additional locations may be considered.