Position Overview

The Quality Manager reports directly to the Laboratory Director, with defined authority for ensuring that the QMS is established, implemented, maintained, improved and compliant with applicable standards. The Quality Manager is also responsible for:

Essential Job Functions

• Creating the audit schedule;
• Coordinating all quality activities of the Analyte Health organization, including laboratory accreditation activities and document control;
• Maintaining and distributing the quality manual and associated quality documents;
• Keeping personnel up to date regarding QMS requirements;
• Planning, coordinating, and conducting internal audits;
• Identifying improvement opportunities;
• Qualifying suppliers;
• Maintaining the Approved Supplier List;
• Maintaining Corrective Action reports;
• Maintaining training records;
• Determining statistical techniques;
• Identifying and reporting non-conformances or potential non-conformances;
• Develop corrective actions to address process non-conformances and potential non-conformances;
• Improving laboratory and/or quality activities on a continuous basis;
• Receiving, processing, and approving Requests/Quotes/Orders;
• Assists with the auditing of the quality function;
• Qualifying suppliers;
• Preparing purchasing documents;
• Participating in the monitoring of suppliers;
• Operating and maintaining storage areas;
• Maintaining personnel files;
• Assists with the auditing of the quality function;
• Disposing of outdated quality records;
• Identifying and reporting non-conformances or potential non-conformances;
• Implementing corrective action to non-conformances and potential non-conformances;
• Improving laboratory and/or quality activities on a continuous basis;
• Responding to customer complaints; and
• Establishing and enforcing suitable handling and packaging methods.

Required Skills/ Qualifications

• A minimum, a bachelor’s degree in biology, chemistry, genetics, clinical laboratory science or a related field;
• At least 5 years operational experience in an AABB and ISO 17025 accredited relationship testing facility;
• 10 years experience with management of Quality Systems;
• Fluent using Google Suite;
• Demonstrate strong written and verbal communication skills when interacting with internal and external customers;
• Work in a biohazard environment, practicing good safety habits; and
• Adheres to PaternityLabs.com core values, safety and compliance policies and procedures.