Quality Manager

Primary Responsibilities

• Ensures center compliance with quality standards and regulations.
• Collaborates with Center Managers to ensure product quality, donor suitability and donor safety.
• Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations.
• Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required.
• Oversight of all aspects of internal and external audits including execution (if applicable).
• Continuously assesses, promotes, and improves the effectiveness of the quality systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, direct employee observation and review of center documents.
• Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment.
• Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.
• Documents and tracks/trends center quality incidents and follows-up on incidents/errors as required; reports critical incidents and problematic trends to Center Manager.
• Reports compliance status to necessary parties.
• Ensures accuracy of donor files.
• Directs the maintenance and calibration of equipment and documentation of procedures.
• Safeguards training documents to ensure compliance with all applicable policies and procedures.
• Ensures that quality control (QC) checks are performed as required and are in acceptable ranges for test reagents.
• QM directs routine verification of the SOP and forms to ensure that they are up to date in the Donor Center’s manual.
• Promotes donor suitability activities and manages donor deferrals as appropriate.
• Prepares quality analysis reports to track issues and set goals.
• Builds rapport with donors to ensure overall customer satisfaction with the Center to support long-term donation.

Job Requirements

• Bachelor of Science degree or equivalent.
• Certified and proficient in quality and compliance.
• Works toward certification from American Society for Quality to be a Certified Quality Auditor.
• Certification as a Designated Trainer for quality area is required.