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

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 65000 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 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)

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:

• 1 year working at VisionGift or 2 years working with a Quality System preferably in tissue banking or blood banking fields is required
• Experience with CAPA structures and root cause analysis preferred
• Experience with process compliance and department audits preferred
• Working knowledge of EBAA Medical Standards and FDA CGTPs preferred
• Strong organizational skills and attention to detail
• Strong analytical critical thinking and problem-solving skills
• Reliable and timely decision maker
• Proficient PC application skills including knowledge of Microsoft Office package Windows and email systems required. Familiarity with Q-Pulse iMonnit viewLinc and iTransplant software preferred
• Excellent communication skills and the ability to work with all levels of the company
• Positive attitude and willingness to work pro-actively and with a team
• Subject matter is sensitive and requires discretion.
• Minimal travel may be required.

Benefits

• Medical dental and vision employee premiums paid in full on some plans
• Paid parental leave after 1 year of service
• Time off policies: 3 weeks PTO 7 paid holidays 1 Floating Holiday and 1 DEI holiday
• $20000 employer-paid life insurance policy
• Employer-paid short-term disability
• Voluntary benefits sabbatical leave and more!

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 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.

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