Senior, Quality Assurance Specialist (Bothell, WA) (Hybrid)

• At least 5 years of working experience in a related field in a regulated environment.
• Strong technical writing skill set and be able to critically review reports while effectively inputting and expressing Quality principles.
• Innovative proactive and resourceful; committed to quality and continuous improvement.
• Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
• Demonstrated ability to manage multiple priorities with project planning skills.
• Strong computer skills with MS Office (e.g. Word Visio and Excel) and with Quality Systems (e.g. Document Management System Quality Management System)
• Previous work experience in the following: quality assurance quality systems internal auditing CAPA change control deviation management and compliance.
• Experience interacting with FDA or other regulatory agencies
• Must complete tasks independently notify supervisor of decisions outside of established processes and the ability to build an internal network.
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
• Experience working with FDA QSR relevant ISO guidelines and 21 CFR Part 11
• Working knowledge of ISO14971
• Experience with various Root Cause Analysis Methodologies Training and Deployment
  

• Medical device industry background
• ASQ Certification(s) in a Quality or Regulatory for Medical Device focused subject/topic
• Excellent attention to detail and project management skills.
• Excellent written/oral communication skills required. Must be able to work effectively with diverse groups of people

• Predominantly operates in an office environment. Some work (less than 5%) requires moving and lifting of heavy networking equipment.

• Requires normal visual acuity and hearing.
• Typically employees sit comfortably to do their work interspersed by brief periods of standing walking bending carrying papers and books and extensive periods requiring the use of computer terminals to accomplish work objectives.
• Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.
• Additional skills may be required to perform additional task(s) specific to work location department or line of business.

• Conducts or serves as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations to assure a compliant and optimal approach
• Assure thorough Root Cause Analysis is completed with the CAPA process
• Review and approve CAPA documentation throughout all phases of the CAPA process to ensure compliance continuous improvement meet organization objectives/metrics and increased customer satisfaction
• Participates in internal and external audits as a subject matter expert and/or lead auditor
• Responsible to provide general quality assurance support in the areas of inspection document control and the overall maintenance of the Quality management System
• Applies working knowledge in the application of concepts principles and technical capabilities to perform varied tasks
• Ability to work on projects of moderate scope and complexity with minimal supervision
• Identifies possible solutions to a variety of technical problems and takes action to resolve
• Applies judgment within defined parameters of established procedures and policies
• Receives general guidance and may receive more detailed instruction on new projects
• Attends and participates in departmental meetings. Attends seminars and training sessions necessary to maintain appropriate level of professional competence
• Ensures all department compliance guidelines are met
• Attends all meetings in-services training or continuing education as delegated by the supervisor
• Provides customer focused interactions
• Performs all duties necessary for the department as per department policies and procedures
• Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department

Required Experience:

Unclear Seniority