Document Control Specialist
4 weeks ago
Job Summary
The Document Control Specialist/ Document Control Specialist II / Sr. Document Control Specialist is responsible for administering and maintaining the company's controlled documents, records, and the document control system in accordance with company requirements. This position is a key role to ensure product and quality system documentation meets defined quality standards and worldwide regulatory requirements. This position also supports all documentation activities including review and release of change requests and provides guidance to users of the document control processes.
Duties & Responsibilities
Document Control Specialist/ Document Control Specialist II / Sr. Document Control Specialist
- Administration of the document control system to include:
- Administering and maintaining changes to documents in accordance with company requirements
- Issuing numbers
- Tracking of all routing and approval stages
- Ensuring new documents and records are consistent with company procedures; reviewing all documentation for accuracy, completeness and consistency in content, format, files and approvals
- Managing external standards
- Controlling quality records
- Compiling data and generating requested reports
- Training users on the document control system and procedures
- Filing
- Understand and follow company rules and regulations;
- Perform all other duties consistent with the position as assigned or required;
- Assist internal users in the generation of change orders for documents as assigned;
- Edit documents for correct formatting per procedural requirements during generation of change control processes.
- Serve as back-up to Document Control Supervisor when supervisor is absent by supervising all day to day activities in Document Control, and providing guidance and support to staff of change control processes
- Serve as back-up to Document Control Supervisor to train new hires or junior staff in the Document Control department.
- Must have computer skills and experience working with spreadsheets, word processors, and database programs;
- Must have previous Document Control experience.
- 1 - 2 years of Document Control or Quality experience for Document Control Specialist
- 3 - 5 years of Document Control or Quality experience for Document Control Specialist II.
- 6 or more years of Document Control or Quality experience for Sr. Document Control Specialist.
- Ability to read and understand general correspondence, periodicals, and procedures;
- Experience working on a team within a document control or quality department;
- Demonstrated problem-solving capabilities;
- Customer driven with sense of urgency/priority in responding to customer's needs;
- Ability to work under pressure while completing assignments;
- Experience in mentoring and coaching staff in the Document Control department.
- Advanced computer skills and experience working with Microsoft Office Professional including Word, Excel, PowerPoint, Vizio, and database programs;
- Demonstrated knowledge and basic proficiency with electronic document management systems;
- Experience working in a medical device industry and familiarity with basic cGMPs;
- 2 years of experience with Agile PLM systems;
- Experience with ERP systems;
Education
High school diploma or equivalent is required. Additional training in change control and change requests is preferred.
Compensation: The anticipated range for this position is $26.00 to $38.00 per hour. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.
Physical Requirements/Work Environment
This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.
The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.
About Us
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.
Masimo is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state or local law.
***NO AGENCIES PLEASE*** Thank you
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: click here
About the Team
Our Quality teams work closely with Regulatory Affairs and Engineering to ensure that the manufacturing processes outlined for each product are strictly followed and meet the appropriate FDA standards and specifications.
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