Manufacturing Documentation Specialist

Manufacturing Documentation Specialist -

• 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 the use of structured writing and content management
• Participate in the creation and maintenance of Management Review materials including the oversight and reporting out 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.)

This is an onsite role, based in Corona California with the general work hours of Monday - Friday, 8 am - 5pm.

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 by 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 everyone is aligned 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 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 in an electronic ERP system
• Ability to sit, stand, lift, bend and stoop numerous times throughout the day.
• Technical Writing experience preferred
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Management System, Quality Policy and all other documented quality processes and procedures.

Disclaimer

This job description in no way states or implies that these are the only duties to be performed by the employee in this position. It is not intended to give all details or a step-by-step account of the way each procedure or task is performed. The incumbent is expected to perform other duties necessary for the effective operation of the department and the company.

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. Affirmative Action Policy Statements

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. Please note, this includes the COVID-19 vaccination.

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 Saving Plan with employer match, Employee Discounts, Tuition Reimbursement, Daily Pay program, Employee Assistance Program, and wellness programs.

Agiliti is an equal opportunity employer and provides reasonable accommodations to employees and applicants consistent with state and federal law.

Agiliti

This range represents the low and high ends of the Agiliti pay range for this position. This base pay range information is based on the market locations shown. For sales positions, this range combines the base salary and the target incentive pay. The actual pay offered may vary depending on several factors including geographic location, experience, job-related knowledge, skills, and related factors. Dependent on the position offered, short-term and/or long-term incentives may be provided as part of the compensation. Applicants should apply via Agiliti's internal or external career site.