DCI Donor Services, Inc. · 1 day ago
Quality Compliance Coordinator
DCI Donor Services, Inc. is dedicated to saving lives through organ and tissue donation. They are seeking a Quality Compliance Coordinator to assist with the development and implementation of corrective action plans and validation activities while ensuring compliance with regulatory standards.
Health Care
Responsibilities
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. Ensures compliance to all regulatory and accreditation entities standards as well as internal DCIDS Policy, SOP, and Work Instructions
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 written validation protocols, written validation reports, and re-qualification or addendum reports when required
Maintains all existing licensure or registrations for their respective region. Assists with new applications for licensure or registration (when applicable)
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
Qualification
Required
Associate's degree required
Working knowledge of computers, Microsoft office, Word, Excel, Power Point required
3+ years of auditing experience in healthcare, medical device, or manufacturing industry
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
Ensures compliance to all regulatory and accreditation entities standards as well as internal DCIDS Policy, SOP, and Work Instructions
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 assist with validation activities for new equipment, re-qualification of existing equipment, software verification, etc
Maintains all existing licensure or registrations for their respective region
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
Preferred
Bachelor's degree in a health-related field preferred
OPO experience in a quality system management and medical records preferred
Current work experience within an OPO or Tissue Bank setting preferred
ASQ Certified Quality Improvement Associate (CQIA), ASQ Certified Quality Auditor preferred
CEBT, CTBS, CPTC preferred
Benefits
Up to 184 hours of PTO your first year
Up to 72 hours 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
Company
DCI Donor Services, Inc.
DCI Donor Services’ family of companies includes DCI Donor Service Tissue Bank and organ procurement organizations in California, New Mexico and Tennessee.