Quality Assurance Manager
- Responsible for maintaining and continuously improving the Quality Management System (QMS) to 21 CFR 820.
- Responsible for risk management documentation for products and processes; identifies and updates failure modes and related process/product improvements by facilitating teams and implementing required changes.
- Handle received complaints and subsequent root cause investigations.
- Inspect manufactured products throughout the manufacturing process to assure products meet specification; including receiving, in-process, and finished device acceptance activities per 21 CFR 820.80 and QMS.
- Manages manufacturing equipment maintenance and calibration and creates maintenance plans for new equipment.
- Reviews, approves and generates engineering Change Orders (COs) for controlled designs and documentation: verification, validation, monitoring and inspection methods, procedures, and test protocols; specific to assigned product line(s) and processes and production control(s).
- Evaluates and participates in the selection of suppliers by monitoring supplier performance, through collection and trending of data and performing supplier quality audits, as required. Manage all SCAR activities.
- Reviews nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
- Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.
- Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of: quality policy, quality objectives, audit results, analysis of data, CAPAs, etc.
- Evaluates the work environment in which product is manufactured, and ensures it is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls.
- Lead determination of US regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
- Lead all Vigilance activities.
- Maintains all applicable regulatory registrations/accounts including FDA facility and device listings and eMDR.
- Identifies guidance documents, international standards, FDA Consensus Standards and assists teams with their interpretation.
- Prepares regulatory submissions to the FDA (primarily Premarket Notifications for Class II devices)
- Interacts with various levels of management, external agencies, and companies.
- Assist with analysis and making recommendations regarding complaints received and whether they are MDR; participates in complaint-related meetings.
- Assist with developing, maintaining and analyzing department systems and provides training when needed. Manages all personnel training to QMS documents.
- Leads FDA facility inspections/audits and other governmental inspections as directed.
- Participates in design and development activities.
- Education and/or experience equivalent to a bachelor's degree in the Biomedical Engineering, Life Sciences, or equivalent field.
- Demonstrated working knowledge of 21 CFR 820 Quality Systems Medical Devices, ISO14791, and other medical device standards as appropriate.
- Working knowledge of statistical methodologies, quality control and manufacturing tools, such as applied statistics.
- Demonstrated working knowledge of eQMS systems, such as Greenlight Guru or Qualio.
- Demonstrated working knowledge of Medical Device Regulation 2017/745 (MDR), MDSAP, Guidance Documents for SaMD and Custom Devices