Responsibilities:
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.
Performs other related duties and tasks, as required.
Qualifications:
Required:
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.
Preferred:
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,
Reports to:
CEO
Job Type:
Full-time
Pay: $90,000.00 - $110,000.00 per year
Benefits:
Schedule:
Supplemental Pay:
COVID-19 considerations:
Vaccination required, boosters encouraged, masking may be required at times depending on community spread.
Ability to commute/relocate:
Experience:
Work Location:
One location
