BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Quality Engineer to work for a leading San Diego biotechnology company.
This position will be responsible for working with the Associate Director of Quality to maintain an ISO13485 & 21CFR Part820 compliant Quality System for a developer of in vitro diagnostics. Reports to the Associate Director of Quality. Emphasis will be placed on:
Manage MasterControl system and configuration for documentation and training modules
Maintain DHFs in compliance to established procedures;
Execute trend analysis on Quality Systems for input into established Management Review procedure;
Assist in investigations and CAPA (leading root cause analysis & writing documentation);
Write software validation documentation;
Responsible for ensuring internal/ external Quality System Requirements are adhered to throughout product and process lifecycles.
Reporting on all of the above listed functionality
Job Requirements & Summary:
Author documents for the Quality System including procedures, forms, and templates. Assist with review, editing, and implementation of Quality System documents.
Manage Master Control System documentation and training modules.
Create Master Control user documents.
Review documents for completeness, consistency, content, and format prior to uploading and routing in MasterControl.
Responsible for the organization of MasterControl including the creation of vaults, routes, training, and custom reports. Improve user interface with the MasterControl System and conduct training on the system as required.
Develop and maintain an efficient method for the flow of documents through the MasterControl system in accordance with relevant document change control procedures.
Responsible for organization and maintenance of Quality System Records and paper record retention of Quality System records.
File, maintain and audit Design History documentation.
Develops and executes (as required) training on GxP and annual Quality System training.
Conducts internal and supplier audits as lead. Writes audit plans, audit reports, and associated non-conformances and CAPAs. Performs and leads root cause analysis with input from subject matter expert.
Lead root cause investigations and documentation for non-conformities. Reviews non-conformities for compliance and presence of objective evidence.
QA lead for calibration and preventive maintenance programs.
Creating and writing the following technical documents associated with the validation and implementation of a CRM (Customer Relationship Management system), an Inventory Management system, and an upgraded Document Management system: Requirements Specification, Risk Analysis, Verification / Validation Plan, Verification / Validation Protocol, Validation Report, & Traceability Matrix.
Identifies, initiates and leads process and compliance improvement. Implements improvements and methods for measuring effectiveness of changes.
Identifies, tracks and reports key Quality Metrics for input into Management Review.
In-Depth knowledgeable of federal and other regulations, e.g. QSRs (Part 820 & Part 11), IVDD, ISO 13485.
Performs other duties & projects as assigned.
Preferred educational background and experience
BS/BA degree in science or technical discipline or higher.
Typically 7+ years related experience.
Strong emphasis placed on working with technical disciplines and understanding of product and process technologies
Experience with federal, 3rd party agencies or regulatory agencies, e.g. 812 QSRâ€™s, ISO, ISO 13485, CMDR) and statistical sampling plans.
Ability to work on multidisciplinary teams.
Identifies and addresses all complexities of compliance issues
Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks
Demonstrates problem-solving and troubleshooting skills
Strong verbal and written communication skills
Demonstrates time management, decision making, presentation, and organization skills required.
Proficient with Microsoft Office and Visio.
Willing and able to travel as required (~20%)
BioPhase Solutions - 14 months ago