Quality Program Specialist - Regulatory Affairs (Hybrid-Portland, OR)

Job Description

Job Description

Description :

Make a difference in the lives of others by helping give the gift of sight!

VisionGift (VG) is a non-profit organization founded in 1975 by Lions Clubs of Oregon, which recognized the need for an eye bank to provide ocular tissue for transplants, research and medical education.

Since its inception, over 65,000 people have received the gift of sight from tissue procured and screened by VisionGift, which works closely with transplant surgeons. Additionally, ocular tissues have been utilized for valuable research projects and surgical training.

Please visit www.visiongift.org for more information on our organization.

The Quality Program Specialist (QPS) is responsible for carrying out day-to-day activities of the VG

Quality Program and / or contracted partner Quality Programs under the direction of the Quality Program

Manager.

Essential Functions

• Participate in the internal audit program, which includes audits of eye donor medical charts, tissue processing events, laboratory maintenance records, and staff training documentation.
• Participate in administration of document control system, including managing documents shared with other agencies.
• Perform initial and ongoing vendor qualifications for companies performing manufacturing steps on behalf of VG.
• Complete initial and ongoing state, federal, and international registrations or licensure.
• Review postoperative data and investigate reported adverse reactions. When applicable, submit findings for review to management and Medical Director for final tissue imputability determination.
• Perform external reporting to various state health agencies, EBAA, and FDA, as applicable, of adverse reactions and communicate outcomes with consignees.
• Participate in CAPA related activities, including customer complaints, deviation discoveries, DFPs etc.
• Participate in IQOQPQ projects for new or repaired equipment as needed.
• Participate in annual logger calibration or data validation projects as needed.
• Be available to staff to assist with compliance and quality questions or problems.
• Participate in continuous improvement efforts including identification of processes needing improvements and taking the lead to initiate those improvements when necessary.
• Assist with VisionGift external audits as needed (e.g. EBAA site inspections, FDA inspections, customer inspections)

Requirements : Education :

Postsecondary coursework in health care, science, technology, or related field is preferred.

Experience in anatomical donation, regulatory affairs, or quality systems may substitute for formal

education.

Experience / Skills :

Benefits

NOTICE TO APPLICANTS :

Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet 100% of the qualifications listed in the job post. We are more interested in finding the best candidate for the job, and encourage you to apply, even if you do not meet every qualification listed. If you are unsure if you meet the qualifications of this role please email hr@visiongift.org to discuss your application.

Please read this job description carefully and ask for clarification if you have difficulty understanding the functions of this job.

Please describe any accommodations that you need in order to perform this job.

PM19