Supervisor - DQA

Position Overview:

Assist DQA Management in the daily operation and oversight of the Donor Quality Assurance team to ensure all charts are flowing through the department with minimal delay. Act as a technical resource to DQA Technicians, Analysts and Specialists. Exercise discretion to reduce waste and variability in processes. Initiate and provide consultation to management for cause-identification and problem-resolution for various types of quality investigations. Ensure that all areas identified under "Principal Responsibilities" are accomplished in an efficient, professional manner.

Position Responsibilities:

• Perform personnel assessments and reviews for direct reports.
• Act as technical reference to manager and other departments.
• Provide support and act as a technical resource to DQA Specialists, Analysts and Technicians with donor chart reviews, eligibility questions, and processing of recovery partner charting information.
• Support DQA Process Specialist in training of direct reports.
• Participate in project teams to provide compliance input for donor and recipient information/impact.
• Assist DQA staff with the evaluation and assessment of issues concerning non- conforming donor records.
• Assist management with donor chart return process for recovery partners and the DQA team by identifying inconsistencies and supporting peer to peer process improvements.
• Use Lean and Six Sigma principals to reduce waste, variation, and decrease cost within the DQA department.
• Provide input to management and DQA Process Specialist to facilitate the process for new, revised, and obsoleted documents (policies, procedures, forms, templates, etc.) as they pertain to the job.
• Aid management and DQA Process Specialist in assuring that specifications, procedures are periodically reviewed for accuracy, validity and functionality.
• Lead or assist in the investigations for non-conformances, out-of-specification, CAPAs, and other investigations using root cause analysis tools.
• Provide support during FDA, Notified Body, and third-party inspections.
• Present data and other important information to management and peers.
• Participate in project teams that impact the DQA department.
• Provide support for additional assignments as delegated by department manager.
• Effectively complete "other" functions that may be assigned.

Qualifications:

• Bachelor's Degree, preferably in the Life Sciences, or equivalent work experience.
• Minimum 5+ years' experience in a regulated industry with an in-depth knowledge of medical records, AATB and tissue standards.
• Good oral and written communication skills.
• Ability to analyze Quality Data.
• Lean Six Sigma certification is preferred.
• Good collaborative skills, effectively manage/prioritize numerous projects, and ability to work with a cross-functional team.
• Demonstrates reliability and leaderships skills.