JOB TITLE: Quality Assurance Engineer-Document Control
DEPARTMENT: Quality Assurance
REPORTS TO: Senior Director Quality Assurance
Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving health outcomes through the identification, validation and commercialization of novel biomarker tests. To support the commercialization of its novel biomarker products, including the FDA-cleared NephroCheck Test for acute kidney injury, Astute Medical is seeking an energetic, experienced, and self-motivated individual for the position of Quality Engineer-Document Control.
This position will be responsible for working within the Quality Assurance team to ensure Astute Medical maintains compliance to applicable regulatory requirements including those for ISO13485 & 21CFR Part 820, and establishes compliance as needed to modified or new regulations. This position will be a Quality Assurance Engineering position with responsibility for management of the Document Control System at Astute Medical.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- This position will have the responsibility for compliance of the Quality Systems related to Training, Document Control, and Records Retention.
- Ownership of the configuration and maintenance of the Document Management System (MasterControl) at a system administrator level to ensure the system is compliant with external regulatory requirements and internal requirements.
- Responsible for the review and assessment of MasterControl release notes against business and quality requirements to determine if upgrades and/or patches are required. Present recommendations to a cross functional team. Coordinate, lead, and execute required verification and validation activities associated with changes to the system.
- Optimize processes and corresponding procedures in compliance with regulatory requirements for identifying, accessing, and maintaining internal documents and records as well as records from external sources (e.g., records required for external partners). Establish a method for organizing, filing, and retaining electronic records within the Design History Files.
- Establish Design History Files/Medical Device Files, as needed. Organize and manage the documentation associated with Design History Files during the product life cycle process. Audit Design History Files for compliance to internal requirements.
- Write and execute Quality Plans for Quality System process improvements.
- Support external and 3rd party audits by organizing and leading back room activities, responsible for the review of records to ensure regulatory and quality requirements have been met prior to being shown to the auditor.
- Responsible for periodic procedure reviews and facilitating procedure updates with process owners.
- Execute internal audits, including writing plans and reports. Conduct opening and closing meetings for internal audits. Responsible for developing, managing, and maintaining the internal audit schedule for internal audits in compliance with regulatory and company requirements. This includes coordinating with auditors and auditees assign ownership and timing of each audit.
- Responsible for investigating and documenting NCRs/CAPAs within the Quality System as well as reviewing and approving NCRs/CAPAs conducted by other departments. Responsible for review of actions to close NCRs/CAPAs, developing and conducting effectiveness verifications, and tracking the status of NCRs/CAPAs. Responsible for developing CAPA metrics as well as scheduling, leading and presenting monthly CAPA metrics to CAPA owners and Management. Identify trends, investigate adverse trends, and present solutions.
- Identify, initiate, and lead process and compliance improvement as requested.
- Performs other duties & projects as assigned.
BS/BA degree preferred
- Typically 4+ years related experience in the regulated industry
- Possess in-depth knowledgeable and experience of federal and other regulations, e.g. QSRs (Part 820 & Part 11), IVDR, ISO 13485
- System Administrator experience with MasterControl
- Strong emphasis placed on working with technical disciplines and understanding of product and process technologies
- Experience with 3rd party audits
- Ability to work on multidisciplinary teams
- Identifies and addresses all complexities of compliance issues
- Demonstrates problem-solving and troubleshooting skills
- Strong verbal and written communication skills
- Demonstrates time management, decision-making, presentation, and organization skills
- Proficient with Microsoft Office and Visio
While performing the duties the employee is:
- Constantly required to use computers and other office equipment
- Frequently required to communicate with others
- Frequently required to sit
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Work weeks exceeding 40 hours are required as necessary.