Quality Assurance/Document Control Contractor (Vista, CA)
DEPARTMENT: REGULATORY AFFAIRS/QUALITY ASSURANCE
LOCATION: Vista, CA. (local candidates only)
The QA/Document Control Contractor will be part of RA/QA supporting the Quality System, specifically in the design, production and new product launch, as well as meeting quality and business objectives relating to change control, configuration management, and inspection activities including support of product data, business processes, production processes, and quality systems processes.
The QA/Document Control Contractor must be able to work with minimal supervision in an FDA GMP/QSR and ISO regulated environment.
- Creating, writing, editing, proofreading, preparing new or revised documents for final release into the QMS as required.
- Process Change Orders including initiation, review/analysis, notification of approvals, issuance of new documents, and final closure.
- Train others on how to initiate and complete Change Orders, Deviations and Training Records effectively.
- Assist in conducting Change Control Board meetings when necessary.
- Manage and maintain the Document Control Quality Management System of released and current revision documents, archiving of previous revisions or obsoleted documents, Training Records, etc.
- Maintain the Training Matrix and all employee training records.
- Develop, trend, and report Quality Metrics as related to Document Control activities, such as Change Order processing times, training record notification responses, etc.
- Perform Receiving and In-Process Inspection of electro-mechanical components, assemblies, and finished devices.
- Support internal and external agency audits.
- Assist with special projects and other QA/QC duties as assigned.
- Excellent organizational, grammar, spelling, and communication skills (both oral and written), responsiveness, attention to detail, filing skills, and teamwork abilities.
- Knowledge of the FDA’s GMP Quality System Regulation (QSR), ISO 13485, and experience with medical device components/assemblies/devices.
- Experience in a regulated environment in Document Control is required.
- Experience in QC Inspection of Device History Records (DHRs) and electro-mechanical components, assemblies, and finished devices is highly desired.
- Proficient and accurate computer skills with word processing (Word), spreadsheets (Excel), Outlook, PowerPoint, and Adobe Acrobat. Visio experience a plus!
DESIRED SKILLS and EXPERIENCE:
- High School Diploma is required.
- A minimum of 5 years Document Control experience in a medical device design and manufacturing FDA/ISO regulated environment is required.
- Hands on experience with quality assurance systems to comply with regulations and pass audits.
- Knowledge of inspection tools such as calipers, surface blocks, height gages, etc.
- High impact, results oriented, team player experienced in driving performance and providing assistance with winning strategies.
- Strong interpersonal skills and ability to work with a diverse team of professionals.