Manager, Document Control
Masimo - Irvine, CA
posted 4 days ago
About the position
For over thirty years, Masimo has been expanding the boundaries of noninvasive monitoring to improve patient outcomes and reduce the cost of care. Today, Masimo delivers a portfolio of hospital-trusted monitoring solutions to help increase patient safety, health, and wellness in the hospital and at home. When you join our team, you'll be part of a culture that's driven by passion, challenging the status quo, and making an impact in the lives of others. The Document Control Manager is responsible for administering the company's controlled documents in accordance with company requirements. Establish and maintain procedures for maintaining documents and change control of documents. Determine and enforce, through functional groups, document control requirements to ensure the company meets internal and external needs. Evaluate and develop improved techniques for the control of documents. Is directly responsible for implementation, administration and maintenance of the document control system. Reports on the performance of the document control system for review and as a basis for improvement of the document control function. Supports configuration and change control, data management, new product introduction, sustaining engineering and production projects and process analysis for quality initiatives. Performs other duties consistent with the position, as required or assigned.
Responsibilities
- Administer the company's controlled documents in accordance with company requirements.
- Establish and maintain procedures for maintaining documents and change control of documents.
- Determine and enforce document control requirements to meet internal and external needs.
- Evaluate and develop improved techniques for the control of documents.
- Implement, administer, and maintain the document control system.
- Report on the performance of the document control system for review and improvement.
- Support configuration and change control, data management, new product introduction, sustaining engineering, and production projects.
Requirements
- Four year technical degree or equivalent education and work experience.
- Thorough understanding of FDA regulations (QSR) and ISO 13485:2003 standard.
- 5 years of broad Document Control experience.
- 2 years minimum experience in managing technical documentation and Engineering change release management.
- Administration of Change Control Board process.
Nice-to-haves
- Additional training in Document Control (i.e. courses/seminars in Engineering Change control and Engineering Change Requests).
- Prior experience with Agile, PDM systems.
- Experience with ERP systems.
Benefits
- Medical
- Dental
- Vision
- Life/AD&D
- Disability Insurance
- 401(k)
- Vacation
- Sick
- Holiday
- Paid Maternity Leave
- Flexible Spending Accounts
- Voluntary Accident
- Critical Illness
- Hospital
- Long-Term Care
- Employee Assistance Program
- Pet Insurance
- On-site Wellness Clinic
- Fitness Center
- Cafe
