Job Title: Quality Document Control Specialist
Job Summary:
The Quality Document Control Specialist is the subject matter expert for change control at NuSmile. He/she is responsible for maintaining and/or organizing many Quality Management System (QMS) processes which are assigned to this position (both physical and electronic) so they are neat, orderly and readily retrievable, including but not limited to Change Request (CR) processing, quality training associated with CRs, Device History Records, and Device Master Records (DMRs)). The Quality Document Control Specialist analyzes changes proposed by Regulatory, Manufacturing, Product Development, Customer Service, Sales, or Marketing to determine the impact of changes on the QMS and works with subject matter experts to implement any changes needed. The QualityDocument Control Specialist working with the Regulatory Quality Specialist compiles the annual PMS report and will upload PMS reports into EUDAMED. The Quality Document Control Specialist acts as the primary backup for the Senior Quality Specialist. The Quality Document Control Specialist will support and exemplify NuSmile’s core values of outstanding customer service and the highest product quality, working to proactively identify and resolve any issues affecting the efficiency and/or productivity of the Document Control function and any other Quality functions assigned, looking for ways to continuously improve processes.
Job Description:
The primary responsibilities of the Quality & Document Control Specialist include and are not limited to the following:
Document Control / Change Management
- Analyzes the effect of proposed changes in processes and documentation to QMS. Works with department heads/subject matter experts to implement any needed changes.
- File quality records for all controlled documents (other than those that are the responsibility of other department members) including but not limited to Quality System Procedures (QSP), Work Instructions (WI), Labels (LBL), Test Methods (TM),Device History Records, Device Master Records (DMR) and Raw Material Specifications (RMS & RMS-LBL) according to retention policies defined in the QMS.
- Issues CR #s and maintains Change Request Log
- Initiate/process Change Requests accurately and quickly.
- Manage revision history for all QMS documents and ensure QMS document changes are accurate.
- Update all QMS documents being processed to the most current format and ensure format consistency and accuracy. Files original documents associated with all Change Request in the appropriate binders. file folders, including both obsoleted documents and effective documents.
- Issue lab books and maintain its log.
- Generate or edits existing quality documents as needed.
- Issues IQ, OQ, IQ/OQ, PQ, and PV numbers and maintains log.
- Composes annual Master Validation Report.
- Provide support to Quality Assurance/Regulatory Affairs team where needed.
Device History Records – Crowns, Space Maintainers, and BioCem Products
- Inspect/accept Class 2 finished products according to work instructions.
- Review Device History Records for completeness, accuracy, and final release, filling out DHRs completely and accurately and filing them correctly.
- Generate Certificate of Analysis (COAs) upon request
Device Master Record (DMR) Maintenance, and Technical File Maintenance
- Maintain Device Master Records (DMRs) ensuring that all new/removed elements making up any NuSmile Medical Device are added or removed on the DMR as part of ongoing Change Management.
- Coordinates with responsible departments to update QMS Systems for which they are responsible as they are processed through the Change Request System. Tracks revision requests and make sure that the revisions are made. Assists in implementing these changes whenever possible.
QMS Maintenance and enhancement
- Revises QSPs applicable to responsibilities based on changes in business or regulatory requirements.
Post Market Surveillance
- Coordinates with Regulatory Quality Specialist to compile Post Market Surveillance annual report for all applicable product lines.
- Manages Post Market Surveillance entries into EUDAMED through product life cycle.
Training
- Trains employees on QMS processes and procedures associated with change requests, with the assistance and under the direction of department managers and other subject matter experts as appropriate.
- Maintains all employee quality system training records.
Quality Meetings and Management Reviews:
- Quality Meetings – Maintains QA tracker for responsibilities/projects and report progress in scheduled QA meetings.
- Management Reviews – Prepares content for assigned areas of responsibility and presents in Management Reviews.
General:
- Scan, image, copy, organize, file and maintain documents for all the systems for which you have primary responsibility adhering to company’s document retention procedures.
- Participate as a member or leader of Quality Teams as assigned, giving 100% to make the team’s work efficient and effective.
Requirements:
- High school diploma or equivalent.
- Ability to author QMS documents (QSP, QSP forms, RMS, PMS reports, etc.) in areas of responsibility.
- Highly organized.
- Detail orientated with high level of accuracy in data input, documentation formatting and content review.
- Proficient with Microsoft Office Suite (Word, Excel, PowerPoint, Visio) and Adobe Products.
- Strong command of the English language, both verbal and written and ability to effectively communicate working with cross-functional team members in a collaborative manner.
- Ability to prioritize and multi-task with little supervision. Punctual and flexible in work assignments.
- Positive attitude, enthusiasm, professionalism, and strong work ethic with high level of integrity and ethics.
- Self-directed, ability to work independently and highly motivated. Carries out duties efficiently in a timely and accurate manner.
Preferred
- At least 1 year of experience in in document control.
- Undergraduate degree
- Bilingual (English / Spanish)
- Has completed ASQ courses and obtained certificates applicable to the position.
Job Type: Full-time
Pay: $22.36 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
Ability to commute/relocate:
- Houston, TX 77008: Reliably commute or planning to relocate before starting work (Required)
Experience:
- Microsoft Office: 1 year (Preferred)
Work Location: In person