- Responsible for facilitating and/or conducting internal and external audits as dictated by the Master Audit Schedule for their respective region.
- Will assist in the development and implementation of Corrective Action Plans (CAP) resulting for an internal or external audit, to include training for required departments. Will maintain and revise the Master Audit Schedule on an annual basis.
- Oversees all areas of non-conformance reporting such as complaints, deviations, root cause analysis, SCAR reporting, etc. Investigates, reviews, and will follow up on all investigations until adequate closure is met.
- Will analyze and review trends within each non-conformance category and report trends for continuous quality improvement efforts. Works with department managers and (Sr.) Director of Quality and Compliance to initiate quality improvement initiatives utilizing quality tools and methodology to test progress and monitor outcomes (PDSA).
- Will monitor, review, and complete vendor or supplier qualifications required to ensure compliance with regulatory and accrediting entities. Will recommend actions for vendors or suppliers that do not maintain compliance requirements or have a high complaint and/or deviation rates.
- Will assist with validation activities for new equipment, re-qualification of existing equipment, software verification, etc. to include writing validation protocols, writing validation reports, and re-qualification or addendums reports when required.
- Maintains all existing licensure or registrations for their respective region. Assists with new applications for licensure or registration (when applicable).
- Maintain and update location training files
- Acts as a role model for the DCIDS and DCIDS Quality Departments by supporting, reinforcing, and exhibiting behaviors consistent with the DCIDS core values; selfless, hardworking, passionate, and dependable.
- Performs other related duties as assigned.
- Associate degree required. Bachelor's degree in a health-related field preferred. OPO experience in quality system management and medical records preferred.
- 3 years or more of auditing experience in healthcare, medical devices, or manufacturing industry. Current work experience within an OPO or Tissue Bank setting preferred.
- ASQ Certified Quality Improvement Associate (CQIA), ASQ Certified Quality Auditor (CQA) preferred. CEBT, CTBS, CPTC preferred.
- Working knowledge of computers, Microsoft office, Word, Excel, Power Point required.
- Exceptional teamwork, communication, and conflict management skills.
- Up to 176 hours (22, 8-hour days) of PTO your first year
- Up to 72 hours (9, 8-hour days) of Sick Time your first year
- Two Medical Plans (your choice of a PPO or HDHP), Dental, and Vision Coverage
- 403(b) plan with matching contribution
- Company provided term life, AD&D, and long-term disability insurance
- Wellness Program
- Supplemental insurance benefits such as accident coverage and short-term disability
- Discounts on home/auto/renter/pet insurance
- Cell phone discounts through Verizon
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Quality Compliance Coordinator - West Sacramento, United States - Sierra Donor Services
Description
Job Description
Job DescriptionSierra Donor Services (SDS) is looking for a dynamic and enthusiastic team member to join us to save lives Our mission at SDS is to save lives through organ donation and we want professionals on our team that will embrace this important work Sierra Donor Services is seeking a Quality Compliance Coordinator to join our team. The Quality Compliance Coordinator will assist with the development and implementation of Corrective and Preventative Action plans, effectiveness checks, and any departmental training that may be associated with the CAPA Plan. This position will oversee non-conformance reporting for complaints, deviations, SCAR reporting, Root Cause Analysis, etc. and any other various reporting requirements to ensure compliance with all state, regulatory and accreditation standards. Works collaboratively with the Corporate Regulatory Compliance Coordinator.
COMPANY OVERVIEW AND MISSION
Sierra Donor Services is the designated organ procurement organization (OPO) for the state of California – and is a member of the DCI Donor Services family.
For over four decades, DCI Donor Services has been a leader in working to end the transplant waiting list. Our unique approach to service allows for nationwide donation, transplantation, and distribution of organs and tissues while maintaining close ties to our local communities.
DCI Donor Services operates three organ procurement/tissue recovery organizations: New Mexico Donor Services, Sierra Donor Services, and Tennessee Donor Services. We also maximize the gift of life through the DCI Donor Services Tissue Bank and Sierra Donor Services Eye Bank.
Our performance is measured by the way we serve donor families and recipients. To be successful in this endeavor is our ultimate mission. By mobilizing the power of people and the potential of technology, we are honored to extend the reach of each donor's gift and share the importance of the gift of life.
We are committed to diversity, equity, and inclusion. With the help of our employee-led strategy team, we will ensure that all communities feel welcome and safe with us because we are a model for fairness, belonging, and forward thinking.
Key responsibilities this position will perform include:
The ideal candidate will have:
We offer a competitive compensation package including:
**New employees must have their first dose of the COVID-19 vaccine by their potential start date or be able to supply proof of vaccination.**
You will receive a confirmation e-mail upon successful submission of your application. The next step of the selection process will be to complete a video screening. Instructions to complete the video screening will be contained in the confirmation e-mail. Please note - you must complete the video screening within 5 days from submission of your application to be considered for the position.
DCIDS is an EOE/AA employer – M/F/Vet/Disability.