Document Control Specialist
21 hours ago
The Document Control Specialist will be responsible for administering the company's controlled documents in accordance with company requirements. This includes establishing and maintaining procedures for maintaining documents and change control of documents.
The ideal candidate will have a thorough understanding of FDA regulations (QSR) and ISO 13485:2003 standard, as well as 5 years of broad Document Control experience. Prior experience with Agile, PDM systems, and ERP systems is preferred.
Key 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 ensure the company meets internal and external needs
- Evaluate and develop improved techniques for the control of documents
- Implement, administer, and maintain the document control system
Requirements:
- Four-year technical degree or equivalent education and work experience
- Additional training in Document Control (i.e. courses/seminars in Engineering Change control and Engineering Change Requests)
- 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, Engineering change release management, and administration of Change Control Board process
Compensation:
The anticipated range for this position is $99,000 - $149,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.
About Masimo:
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.
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