Job Description
Quality Specialist
The Quality Specialist is a member of the quality organization with a high level of proficiency in a number of administrative functions. These functions include Material Review Board processing, incoming inspection, training, as well as support activities related to the documentation control group. The quality specialist must possess the appropriate skill set to support each of these functions with equal proficiency.
RESPONSIBILITIES:
Documentation Control
ESSENTIAL REQUIREMENTS:
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The Quality Specialist is a member of the quality organization with a high level of proficiency in a number of administrative functions. These functions include Material Review Board processing, incoming inspection, training, as well as support activities related to the documentation control group. The quality specialist must possess the appropriate skill set to support each of these functions with equal proficiency.
RESPONSIBILITIES:
- A Quality Specialist will maintain a specialty that will focus on primary responsibilities such as system administration, inspection processing and document control. Each Quality Specialist will also cross train in other areas of the quality organization to strengthen the department and company.
- Responsible for following Cogmedixs Quality Management System, cGMPs and ISO13485 requirements.
Documentation Control
- Understands and follows good documentation practices in a cGMP and ISO 13485 environment
- Organize and review Device History Records (DHRs) at the completion of the manufacturing cycle and ensure all signatures and data are present.
- Scan Device History Records (DHRs) to save electronically and upload to customer FTP sites
- Assists with maintaining the Quality System Documentation Control System including the Master list
- Assist the Quality management with the creation, updating, and processing of new and existing procedures, work instructions, and all other Quality department documentation
- Assists in the development and maintains associate training curriculum, which consists of documentation, training records, training matrix and materials.
- Assists with maintaining project specific work instruction control forms.
- Assists with preparing and deliver curriculum as necessary to support Cogmedix training needs.
- Assists in providing Training Plan / Job Description for employees
- Files training logs within Omnify upon completion of training
- Creates training within Omnify as required
- Coordinates training classes when appropriate.
- Must be proficient in the use of the Omnify Training module
- Assist the Material Review Board manager in the initial processing of non-conforming material into the electronic systems.
- Organize materials to ensure the preservation of the materials
- Able to effectively communicate issues to suppliers, both verbally and through email.
- Prepare materials to be returned to suppliers.
- Assists with gathering quality data for metrics and distribution of production metrics.
- Able to assist Receiving Incoming Inspection by processing incoming material, that require incoming inspection, in the Cogmedix electronic systems.
- Identifies and reports any product or documentation quality problems or discrepancies.
- Ensures products are moved to proper locations as appropriate.
- Documents any non-conformances and ensures all product non-conformance paperwork is complete and is included in the work order package.
- Maintains proper control of device traceability materials and non-conforming material.
- Maintains work area and equipment in a clean and orderly condition and follows prescribed safety regulations.
- Perform all Quality Department administrative functions as required.
- Assist with all FDA, Notified body, Internal and/or customer audit related activities; as needed.
- Coordinate with Quality management on quality problems relating to the product, process and Quality System
ESSENTIAL REQUIREMENTS:
- Attention to details and superior organizational skills.
- Superior customer service attitude.
- Demonstrated skills in administrative roles.
- High School Diploma or equivalent. Further technical training or education preferred.
- Working knowledge of cGMP, QSR, ISO, SOPs, work rules and safety guidelines preferred.
- 2+ years office experience, preferably in a medical device manufacturing organization.
- Advanced computer skills in such areas as Excel, Word, PowerPoint, Project, Visio, ERP, and Database Management preferred.
- Effective communication skills, both written and verbal.
- Must be able to read, write, and fully comprehend English.
- Excellent teamwork, communication, and interpersonal skills.
- A demonstrated commitment to company values.
- Physical requirements Excellent manual dexterity and eye/hand coordination.
- Standing for prolonged periods of time.
- Sitting for prolonged periods of time.
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Numbers & Facts
| Location | West Boylston, MA |
| Industry | Staffing/Employment Agencies |
| Salary | $28 |
| Company Size | 20 to 49 employees |
| Year Founded | 1992 |
| Website | http://thepanthergrp.com |
About Company
The Panther Group is minority owned and certified, making diversity, equity and inclusion core components of our mission.
With our commitment to respecting and empowering our employees as individuals, diversity is a competitive advantage in the marketplace.
The Panther Group has a proven track record of connecting quality talent with the right position. We believe in a hands-on approach, with a focus on building lasting relationships with our Employees and our Clients. Our Employees find flexibility and growth to reach their career goals.
The Panther Group celebrates 25 years of recruitment and workforce solutions expertise.
Skills
- Administrative Skillsunmatched
- Communication Skillsunmatched
- Computer Skillsunmatched
- Control Systemsunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Customer Support/Serviceunmatched
- Data Collectionunmatched
- Database Administrationunmatched
- Detail Orientedunmatched
- Document Controlunmatched
- Documentationunmatched
- ERP (Enterprise Resource Planning)unmatched
- English Languageunmatched
- FDA (Food and Drug Administration)unmatched
- FTP (File Transfer Protocol)unmatched
- High School Diplomaunmatched
- ISO (International Organization for Standardization)unmatched
- Internal Auditunmatched
- Interpersonal Skillsunmatched
- Manual Dexterityunmatched
- Manufacturingunmatched
- Materials Managementunmatched
- Medical Equipmentunmatched
- Medical Organizationsunmatched
- Metricsunmatched
- Microsoft Excelunmatched
- Microsoft PowerPointunmatched
- Microsoft Visiounmatched
- Microsoft Wordunmatched
- Order Deliveryunmatched
- Organizational Skillsunmatched
- Physical Demandsunmatched
- Presentation/Verbal Skillsunmatched
- Product Documentationunmatched
- Quality Controlunmatched
- Quality Managementunmatched
- Quality Metricsunmatched
- Quality System Requirements (QSR)unmatched
- Receiving Inspectionunmatched
- Regulationsunmatched
- Safety/Work Safetyunmatched
- Standard Operating Procedures (SOP)unmatched
- Systems Administration/Managementunmatched
- Systems Maintenanceunmatched
- Team Playerunmatched
- Technical Trainingunmatched
- Traceabilityunmatched
- Training/Teachingunmatched
- Training/Teaching Curriculumunmatched
- Writing Skillsunmatched
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