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Quality Assurance Manager

  • Location Redcar and Cleveland
  • Job type Permanent
  • Reference BBBH135214
  • Salary US$85000 - US$100000 per annum
  • Specialisation Legal
  • Posted July 21, 2022


Quality Assurance Manager

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.



Qualifications:

  • 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