Quality Assurance Director
4 weeks ago
Join Our Team as a Quality Assurance Director
Are you passionate about ensuring the highest standards of quality and compliance? Do you have a knack for navigating complex regulatory environments and leading teams to success? If so, we have the perfect opportunity for you
Position: Quality Assurance Director
Location: Shepeard Community Blood Center - Augusta, GA
Why You’ll Love This Job:
- Impact Lives: Ensure the safety and quality of blood products that save lives every day.
- Leadership Role: Guide and support operational leaders in compliance and quality assurance.
- Innovative Environment: Use your expertise to solve problems and advance business goals in safety, collections, finance, and efficiency.
What You’ll Do:
- Regulatory Compliance: Serve as the subject matter expert in federal and state laws, regulations, and accreditation standards.
- Support Leaders: Provide guidance and interpretation of regulations and standards to operational leaders.
- Problem Solving: Use your regulatory knowledge to proactively advance business goals.
- SOP Oversight: Collaborate with senior leadership to review SOPs, validations, maintenance, storage, and other processes.
- Reporting: Ensure timely and proper reporting of activities, including product recalls, annual reports, and licensure submissions.
- Document Management: Lead the implementation, maintenance, and refinement of a document management system.
- Error Investigation: Develop procedures for investigating, evaluating, correcting, following up, and reviewing all reported errors and non-conformities.
- Training Oversight: Review and provide oversight of training and competency programs in collaboration with department directors.
- Equipment Management: Review equipment qualification, validation, maintenance, and calibration procedures.
- Stewardship: Embody a culture of stewardship for donations and their life-altering impacts.
- Record Review: Oversee record review and coordinate site inspections (FDA, AABB, etc.), monitor follow-up, and provide corrective actions.
- Staff Training: Assist in training and instructing SCBC staff in compliance and quality assurance.
- Strategic Planning: Work with the leadership team to complete the strategic plan and advance the mission and vision of the organization.
- KPI Achievement: Meet Key Performance Indicators (KPIs) assigned to this position.
What We’re Looking For:
- Education: Bachelor’s degree required. Master’s degree in medical technology preferred. SBB highly preferred.
- Experience: Six years of blood bank or quality assurance experience.
- Skills: Familiarity with FDA/AABB regulations, OSHA, and CLIA requirements. Strong organizational, communication, and leadership skills.
- Physical Requirements: Ability to stand, walk, reach, stoop, kneel, bend, twist, and push/pull regularly.
- Working Conditions: High-risk exposure to blood-borne pathogens. Work in an office with adequate light, climate control, and moderate noise. Occasionally work on bloodmobiles and mobile sites where conditions vary.
Ready to Make a Difference?
Join us at Shepeard Community Blood Center and be a part of a team dedicated to saving lives and ensuring the highest standards of quality and compliance. Apply now and help us advance our mission and vision
DISCLAIMER:
This job description is not intended to be all-inclusive. The employee will also perform other reasonable related business duties as assigned by the supervisor or other management.
Management reserves the right to change job responsibilities, duties, and hours as needed. This document is for management communication only and is not intended to imply a contract of employment.
- Pre-Employment Screening: All selected applicants must undergo a pre-employment drug screening.
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