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Quality Assurance Coordinator (Downtown Seattle)

SightLife Surgical was founded in fall 2016 to challenge the status quo of the cornea ecosystem, primarily by driving the systemic change needed to enable innovation and access to treatments for corneal blindness. This cornea-focused organization provides comprehensive services to support ophthalmic surgeons, from corneal tissue and devices to reimbursement consulting and political advocacy. Based in Seattle, SightLife Surgical is a for-profit subsidiary of SightLife, the only non-profit global health organization working relentlessly to eliminate corneal blindness worldwide by 2040. This mission-driven structure maintains the non-profit status of SightLife as the parent organization and adds a for-profit "engine" to power and accelerate achievement of the mission.

To learn more about SightLife Surgical or apply for this position, please visit our website at http://www.sightlifesurgical.com/About/Careers.aspx


Primary Purpose:

Responsible for the monitoring and performance of quality improvement, quality control, quality assurance, process validations, equipment validations and flow charting. Ensures Eye Bank Association of America (EBAA), Federal Drug Administration (FDA), SightLife, and state regulatory standards are followed.

Essential Duties and Responsibilities:

-Maintains routine reports demonstrating performance of SightLife/SightLife Surgical quality standards, Investigate and analyze quality indicator trends.
-Performs internal and external audits and generates reports.
-Performs equipment and process validations and generates reports.
-Reviews and updates the SightLife/SightLife Surgical Policy and Procedure manual and forms as needed for regulatory and process changes following document control policies.
-Responsible for the environmental monitoring of SightLife/SightLife Surgical facilities and processing procedures.
-Performs all required follow up for confirmed positive serologies.
-Initiates and completes reporting for all adverse events, tissue recalls, tissue withdrawals, deviations, departures and regulatory communications as needed.
-Primary host during regulatory inspections.
-Maintains chart room, tracking and monthly chart audits.
-Investigates incidents/complaints and completes corrective and preventive actions as needed.
-Maintains training records for eye bank staff, assures documentation of initial training, annual competency and blood borne pathogens training is completed.
-Maintain overall knowledge of referral, recovery, processing, and distribution processes.
-Performs other projects and duties as assigned.
-In all daily activities, strive to support the Mission, Vision, and Values of SightLife/SightLife Surgical.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required Skills/Knowledge/Abilities:

-Experience with Microsoft Word, Excel and Visio.
-Excellent oral and written communications skills with the ability to interact effectively with all Eye Bank staff.
-Ability to work long hours, nights, and weekends when needed.
-A personal commitment to organ and tissue donation required.

Education and/or Equivalent Experience:

Bachelor's degree and relevant educational or work experience.
Previous experience in biomedical, biologics, or pharmaceutical preferred.

To learn more about SightLife Surgical or apply for this position, please visit our website at http://www.sightlifesurgical.com/About/Careers.aspx